AtomVie Global Radiopharma Inc . is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients' lives by advancing high quality drugs for the treatment and diagnosis of diseases. We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
The Microbiologist will be responsible for completing the day-to-day tasks assigned; this embraces routine microbiological testing including: sterility testing, growth promotion, bioburden testing, microbial identification, and other tests according to the USP and EP.
Conduct routine microbiological testing including: sterility testing, growth promotion, bioburden testing, microbial identification, and other tests according to the USP and EP.
Conduct peer review of laboratory records.
Conduct routine environmental monitoring of cleanrooms according to SOPs.
Be responsible for the maintenance of the AtomVie Microbiology Laboratory according to Health Canada GMPs, including records, procedures, disposal of waste, materials, equipment, and routine operations.
Support calibration/maintenance of Microbiology equipment.
Conduct inventory and management of microbiological materials.
Assist in the closure of Change Controls, Non-Conformances, Investigations and CAPAs as specified in the SOPs.
Assist in the writing of technical documents, customer and internal reports, SOPs, protocols.
Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality.
Conduct investigations for testing failure and non-conformances and implement corrective actions.
Adhere to GMP regulations by maintaining complete records pertaining to all aspects of microbiological testing, routine operations, and equipment maintenance
Understand and work under the Canadian Nuclear Safety Commission regulations.
Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work.
Excel, Google Sheets), and ability to write technical documents and reports.
Good communication skills (in English) and ability to work both independently and cooperatively in a team environment.
Experience in a pharmaceutical cGMP environment, experience in Aseptic Operations, Cleanrooms, and Biosafety Containment Level 2 lab, and working under Canadian Nuclear Safety Commission regulations are assets in this role.
in Microbiology or a related field.
~1 to 3 years of related experience in Microbiological testing such as Growth Promotion, Bioburden, Environmental Monitoring, Sterility and/or Bacterial Endotoxin.
~ This position requires shift work and alternating weekends.
~ Group Health & Dental Benefits (from day 1)
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process.
AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases. We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the RoleThe Microbiologist will be responsible for completing the day-to-day tasks assigned; this embraces routine microbiological testing including: sterility testing, growth promotion, bioburden testing, microbial identification, and other tests according to the USP and EP.
What You Will DoConduct routine microbiological testing including: sterility testing, growth promotion, bioburden testing, microbial identification, and other tests according to the USP and EP.Conduct peer review of laboratory records.Conduct routine environmental monitoring of cleanrooms according to SOPs.Be responsible for the maintenance of the AtomVie Microbiology Laboratory according to Health Canada GMPs, including records, procedures, disposal of waste, materials, equipment, and routine operations.Support calibration/maintenance of Microbiology equipment.Conduct inventory and management of microbiological materials.Assist in the closure of Change Controls, Non-Conformances, Investigations and CAPAs as specified in the SOPs.Support investigations for Micro related failures and non-conformances.Assist in the writing of technical documents, customer and internal reports, SOPs, protocols.Support the Media Fill program.Understand and work under the Health Canada GMP requirements for sterile pharmaceuticals and the Annex to the Good Manufacturing Practices Guidelines Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs).Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality. Conduct investigations for testing failure and non-conformances and implement corrective actions.Adhere to GMP regulations by maintaining complete records pertaining to all aspects of microbiological testing, routine operations, and equipment maintenanceUnderstand and work under the Health Canada and FDA GMP requirements for sterile pharmaceuticals. Understand and work under the Canadian Nuclear Safety Commission regulations. Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work. Complete all other duties as required.
What You Bring to the Role Proficiency with spreadsheets (e.g. Excel, Google Sheets), and ability to write technical documents and reports.Good communication skills (in English) and ability to work both independently and cooperatively in a team environment.Experience in a pharmaceutical cGMP environment, experience in Aseptic Operations, Cleanrooms, and Biosafety Containment Level 2 lab, and working under Canadian Nuclear Safety Commission regulations are assets in this role.
RequirementsB.Sc. in Microbiology or a related field.1 to 3 years of related experience in Microbiological testing such as Growth Promotion, Bioburden, Environmental Monitoring, Sterility and/or Bacterial Endotoxin.This position requires shift work and alternating weekends.Ability to lift and move heavy weights up to 23 kilograms is required.
AtomVie Offers Group Health & Dental Benefits (from day 1) RRSP Matching Program Perkopolis Employee Assistance and Wellness Programs Parking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the RoleThe Supply Chain Coordinator will oversee and support the sales order cycle, forecasting, and demand planning for both GMP and non-GMP radiopharmaceutical production and distribution. In collaboration with other teams, this role will proactively review customer production forecasts, update capacity planning models and prepare customer-facing presentations for internal and external communication as required. Additionally, the Supply Chain Coordinator will oversee the purchasing responsibilities for select materials categories
What You Will DoParticipate in capacity planning activities across all departmentsMaintain and update customer forecasts working in conjunction with Business Development including the development of customer forecast accuracy metricsEnter and maintain sales order, ensuring clear communication across departments.Maintain and trend all Supply Chain related KPIsProduction planning and scheduling for consumable kits as requiredAssist in preparations of customer facing presentations related to inventory reporting and production planningProcess purchase requests following policy guidelines for select vendors.Proactively communicate with various AtomVie teams regarding status of their orders.Assist with month end activities as required.Assist in item and vendor on-boarding at AtomVie and creation in ERP system as requiredRecommend practices to ensure effectiveness and efficiency of strategic initiatives and inventory/warehouse management.Assist in the creation inventory strategies that minimize financial impact and recommend processes to manage materials Investigate and resolve inventory discrepancies in a timely mannerWork alongside purchasing to work within approved budget for all materials and productsDrive continuous improvement aligned with strategic initiatives and improve efficiency Handle the logistics and operations of the Warehouse as requiredComply with safety systems and policies and complete required radiation safety, GMP and TDG trainingPerform all other duties as assigned
What You Bring to the RoleExperience in a pharmaceutical manufacturing company is an assetStrong communication skills written and verbalAbility to work autonomously in a fast-paced environment and to adjust workload based on changing prioritiesFlexibility in hours to ensure production schedules are met and shipment of product is successfulA continuous improvement and quality-focused mindset.
RequirementsCertificate in supply chain or related disciplines or equivalent qualifications in business administration2-5 years’ experience supply chain, purchasing or warehouse/ distribution operationUnderstanding of WHMIS and SDSUnderstanding of Good Distribution and Good Warehousing PracticesWorking knowledge and understanding of GMP, OHSA, FDA, Health Canada guidelines as they apply to materials managementIn depth knowledge or warehouse operations, materials management, logistics and supply chain
AtomVie OffersGroup Health & Dental Benefits (from day 1)RRSP Matching ProgramPerkopolisEmployee Assistance and Wellness ProgramsParking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the RoleThe Facility & Maintenance Supervisor will be responsible for providing overall direction to the Facilities & Maintenance team in the everyday planning and execution of maintenance tasks. This role will also provide direction on the management of 3rd party contractors and work with other internal teams to ensure the site’s contracted services deliverables are executed safely, and efficiently.
The Facilities and Maintenance Supervisor role will support our new facility and establish the systems and business processes essential for GMP operations and site culture development. Success in this role will demand strong collaboration, innovation, and resilience as the site scales up to full GMP manufacturing during the startup phase. What You Will DoOversee and ensure timely completion of the master preventative maintenance schedule, all maintenance tickets and keeping activities up to date and on track. This includes tracking, scheduling and executing the maintenance work in coordination with the Area / Equipment owners across the site(s).Assign Facility and Maintenance tasks to technicians based on the production schedule/customer requirements and assure that employees are at maximum productivity.Coordinate and schedule the planned maintenance activities with the Area / Equipment owners across the site(s). Ensure AtomVie’s facilities are available, clean, maintained, & repaired to the applicable standards.Manage CMMS (Computerized Maintenance Management System) transition, asset management, develop and track maintenance KPI’s.Manage 3rd party vendors and a team of maintenance technicians to troubleshoot issues and perform necessary repairs or replacements of assets.Coordinate and manage contractors/suppliers by defining the scope of work, supervising tasks, and ensuring deliverables are completed as required. Contracted work may include HVAC and electrical maintenance, waste management, pest control, etc.Initiate, review and approve Work Permits as required.Initiate, review and approve annual contracts/renewals will 3rd party contractors.Perform hands-on execution of maintenance tasks, including timely troubleshooting, and correcting performance issues. Lead troubleshooting and repair of a wide range of complex equipment, such as shielded nuclear radiation containment chambers (hot cells), biological safety cabinets (BSCs), isolators, analytical and process equipment, addressing complex electrical, pneumatic and mechanical issuesMonitor and ensure spare parts, consumables, tools, and other equipment needed to maintain assets in optimal working condition are stocked as necessary.Diagnose and correct, on an on-call basis, operational problems as requiredPrepare/review and submit service/calibration reports for approvals and release.Ensure documentation completed in compliance with cGMPs, and AtomVie’s quality documentation. Follow AtomVie SOPs and procedures, support GMP documentation requirements to fulfill all Provincial and Federal regulatory requirementsEvaluate and analyze operating and maintenance records on an on-going basis, identifying problems and potential problem areas for improvement.Initiate and lead change controls and document changes in relation to the preventative maintenance program.Identify, initiate and drive process improvements in relation to the preventative maintenance program.Provide Management with reports related to equipment performance and recommendations related to improvements. Implement modifications to increase performance and reliability as approved by Management.Participate and engage in training provided by AtomVie via consultants or third-party groups for continuous improvement within this role.Prepare and lead the training for new maintenance team hires in relation to the maintenance program – This will include the hands-on training and supporting the new hire with documentation training.Ensures compliance with Health Physics, Health, Safety and Environment protection rules, with engagement of all associates to apply the policies, procedures and regulations applicable to their work.Demonstrate safety knowledge, awareness and compliance with all safety and other job-related policies and procedures.What You Bring to the RolePassion for driving continuous improvements in processes, efficiency, and overall performance through innovative solutions and data-driven strategiesStrong technical experience in troubleshooting and repair of complex technical systems (example: electronic, computing, pneumatic and electro-mechanical, automation systems).Experience in reading and understanding complex electronic and pneumatic drawingsPrevious experience leading a team of direct reports Thrives in a fast-paced setting.Ability to work independently and possess excellent organizational skills.Highly motivated with strong attention to detail
RequirementsA College Diploma/degree in a technical field (Mechanical, electrical, etc.) or relevant experience.Minimum five (5) years of pharmaceutical GMP manufacturing experience, managing a Facility or Maintenance Team.Three (3) years in a supervisory roleGMP experience is a must requirement. Demonstrated ability to successfully prioritize, manage time well, multitask, and troubleshoot.Flexibility and willingness to work weekends, holidays and support on-call 24/7 (rotating schedule).Previous experience in facility/area start-up environments is an Asset.Willingness to work fluctuating start times to meet business needs.Excellent verbal and written communication skills, with expertise in technical report writing and a strong ability to understand and analyze complex systems and trends.Must be able to withstand exposure to temperature variations while performing work outside in winter and summer weather conditions.You will be trained as a Nuclear Energy Worker (NEW). Ability to lift 50lbs, crawl, stoop, crouch, and kneel in small spaces.Other related duties, as required.
AtomVie OffersGroup Health & Dental Benefits (from day 1)RRSP Matching ProgramPerkopolisEmployee Assistance and Wellness ProgramsParking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the RoleThe Facilities & Maintenance Technician will be responsible for hands-on execution of maintenance programs, including timely troubleshooting, root cause analysis, and correcting performance issues. This role will also work with 3rd party contractors and other internal teams to ensure the site’s contracted services deliverables are executed safely, and efficiently. The primary objective is to execute all maintenance activities in alignment with AtomVie’s QMS requirements and GMP regulations.
What You Will DoExecute the planned preventative maintenance activities and ensure the release of equipment for production use. Address maintenance tickets in a timely manner to troubleshoot issues and perform necessary repairs or replacements of assetsTroubleshoot and repair a wide range of complex equipment such as shielded nuclear radiation containment chambers (hot cells), biological safety cabinets (BSCs), isolators, analytical and process equipment, addressing complex electrical, pneumatic and mechanical issuesInitiate and lead nonconformance investigations of equipment issues, aid in the resolution. Implement Corrective Action Preventative Action (CAPA) accordingly.Diagnose and correct, on an on-call basis, operational problems as requiredInitiates Work Permits, performs lockouts, provides contractor escorts, and ensure service completions are reviewed and accepted. Manage spare parts inventory and maintain all assets in optimal working condition.Prepare, and submit executed protocols, work orders and vendor reports, for completeness and accuracy for approvals and release, in compliance with cGMPs, and AtomVie’s quality documentation. Follow AtomVie SOPs and procedures, support GMP documentation requirements to fulfill all Provincial and Federal regulatory requirementsEvaluate and analyze operating and maintenance records on an on-going basis, identifying problems and potential problem areas for improvement.Initiate and lead change controls and document changes in relation to the preventative maintenance program.Identify, initiate and drive continuous improvements in relation to the preventative maintenance program.Responsible for personal safety and the safety of those who are affected by your work.Must be able to recognize hazard conditions, take appropriate workplace safety measures and wear appropriate personal protective equipment to suit the work environment.Participating in compulsory training is deemed necessary for the role.Complete all other duties as required.
What You Bring to the Role Passion for driving continuous improvements in processes, efficiency, and overall performance through innovative solutions and data-driven strategiesStrong technical experience in troubleshooting and repair of complex technical systems (example: electronic, computing, pneumatic and electro-mechanical, automation systems)Experience in reading and understanding complex electronic and pneumatic drawingsThrives in a fast-paced settingAbility to work independently and possess excellent organizational skills.Highly motivated with strong attention to detail
RequirementsA minimum of a College Diploma/degree in a technical field (Mechanical, electrical, etc.) or relevant experience.Minimum two (2) to five (5) years of maintenance experience in GMP environment.Demonstrated ability to successfully prioritize, manage time well, multitask, and troubleshoot.Flexibility and willingness to work weekends, holidays and support on-call 24/7 (rotating schedule).Previous experience in facility/area start-up environments is an asset.Willingness to work fluctuating start times to meet business needs.Excellent verbal and written communication skills, with expertise in technical report writing and a strong ability to understand and analyze complex systems and trends.Ability to lift 50lbs, crawl, stoop, crouch, and kneel in small spaces.Must be able to withstand exposure to temperature variations while performing work outside in winter and summer weather conditions.You will be trained as a Nuclear Energy Worker (NEW).
AtomVie Offers Group Health & Dental Benefits (from day 1) RRSP Matching Program Perkopolis Employee Assistance and Wellness Programs Parking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the RoleThe Manufacturing Process Manager will coordinate the day-to-day operations of multiple production lines/shifts for programs. As Manufacturing Process Manager, you will assign tasks and adjust workloads to meet production schedules and plans, monitor training, assess the progress of the employees and oversee manufacturing quality and safety.
Reporting to the Director, Radiopharmaceutical Manufacturing, The Manufacturing Process Manager will also be responsible for overseeing the manufacturing operations efficiency through improvement projects implementation in collaboration with the Continuous Improvement manager, coordinating production plans with various departments in order to make sure that materials and other resources are in place to support production plan, and continuously monitoring and reporting results out of the shop floor.
What You Will DoEnsure consistent production of radiopharmaceuticals according to operational, quality, and safety requirements.Lead on production planning activities to include production scheduling, materials planning, and reporting.Act as point of contact for other departments and team members to coordinate matters related to manufacturing.Serve as leader for manufacturing related items, troubleshooting, and validations.Ensures that adequate staffing levels are maintained. Monitors overall training progress and reports the information to the Director of Radiopharmaceutical Manufacturing.Oversee and coordinate equipment calibration, maintenance and follows up on associated documentation.Systematically identifies facilities, equipment, utilities and processes that require improvements and ensures these improvements and/or investments are budgeted and effectively implemented.Maintains, edits and reviews manufacturing related standard operating procedures (SOP’s) and Master batch records (MBR’s). leading non-conformance investigations.Ensures that production department is in inspection ready state (GMP, Quality, Safety, HP) and participates in customer and regulatory or agency audits as required.Projects a professional and supportive demeanor while promoting safe and positive working environment.Support Business Development and Product Development teams regarding clients’ relationship when manufacturing inputs are of importance.Monitor and report production results against KPIs and efficiency metrics.Work alongside own supervisor to develop action plans for any decision-making on batch release and to troubleshoot and problem solve critical issues related to production.Inform Quality group of any production problems as well as any concerns with drug product quality immediately.Maintain documentation to fulfill all customer, facility, Provincial, Federal and applicable regulatory requirements relating to nuclear safety and cGMP manufacturing.Adhere to the Health Canada GMP requirements for sterile pharmaceuticals.Complete all other duties as required.
What You Bring to the Role You have experience in capacity planning and scheduling.Demonstrated success in managing and developing people in a GMP manufacturing environment.Ability to establish internal and external networks.You have excelled problem solving skills.Excellent planning, organizing, communication, and collaboration skillsKnowledge of materials management systems or ERP systems applications is a plus.You thrive in a fast-paced setting.
RequirementsDiploma/degree in Chemistry, Biology or related Science.5 - 10 years direct experience in pharma/biotech manufacturing organizations, including experience in aseptic GMP manufacturing industry.Minimum of two years of demonstrated leadership and behavioral competencies in a similar role.Experience in managing different aspects of GMP aseptic production is a must.Knowledge of GMP requirements and guidelines (mainly Health Canada, FDA, and EMA).Flexibility in work schedule to support a 24/7 production environment
AtomVie Offers Group Health & Dental Benefits (from day 1)RRSP Matching ProgramPerkopolisEmployee Assistance and Wellness ProgramsParking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
Job DescriptionAtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the RoleReporting to the Engineering Manager – Facilities & Maintenance, the CQV Technician will assist the Engineering department with tasks such as equipment calibrations, recertifications, and documentation execution in compliance with GMP practices. This role will also coordinate third-party contractors and contribute to the continuous improvement of the engineering department. The primary objective is to support the execution of all CQV activities in alignment with standards and AtomVie’s requirements
What You Will DoManage and execute vendor and internal calibration programs, including the review and approval of service records and reports (e.g., calibration certificates, completed protocols, work orders, and vendor reports) to ensure completeness and accuracyCollaborate across teams and locations to ensure calibration programs are implemented and maintained in accordance with cGMPs and the Validation PlanPerform equipment re-qualification and re-validation activities across AtomVie. Such as executing smoke studies for Grade A Hot cells, BSCs, Isolators and temperature / humidity mapping for Controlled Temperature Units, material storage areas.Co-ordinate with the production and other teams to ensure that calibration and re-qualification activities do not impact on their schedules.Support the development and execution of all commissioning and qualification documentation related to thermal studies, validation studies for equipment, facilities, development studies and software validation.Investigate and troubleshoot problems relating to any CQV tasks. Provide technical assistance during investigations of equipment and validation issues, aid in the resolution of validation deviations and protocol discrepancies.Address non-conformances related to deviations occurring when equipment fails to meet acceptance criteriaDemonstrate safety knowledge, awareness and compliance with all safety and other job-related policies and procedures.Assist or lead the troubleshooting and repair of production and QC related equipment as neededCo-ordinate with the direct supervisor and technicians to ensure management and QA are informed of compliance status and adherence to commitments.Participate in compulsory training as deemed necessary for the role.Complete all other duties as required.
What You Bring to the Role Passion for driving continuous improvements in processes, efficiency, and overall performance through innovative solutions and data-driven strategiesSolid understanding of cGMP validation requirements / guidelines and current industry practice.Thrives in a fast-paced settingAbility to work independently and possess excellent organizational skills.Highly motivated with strong attention to detail
RequirementsA minimum of a College Diploma/degree in a technical field or related (Engineering, Metrology, Pharmaceutical Sciences etc.,) or relevant experience.Minimum Two (2) to five (5) years of applied technical experience within the CQV space of the pharmaceutical, health sciences, or biotech industries, managing equipment with direct impact to product testing and quality.Demonstrated ability to successfully prioritize, manage time well, multitask, and troubleshoot.Excellent verbal and written communication skills, with expertise in technical report writing and a strong ability to understand and analyze complex systems and trends.Ability to lift 50lbs, crawl, stoop, crouch, and kneel in small spaces.
AtomVie Offers Group Health & Dental Benefits (from day 1) RRSP Matching Program Perkopolis Employee Assistance and Wellness Programs Parking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
Job DescriptionAtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the RoleThe Supply Chain Coordinator will oversee and support the sales order cycle, forecasting, and demand planning for both GMP and non-GMP radiopharmaceutical production and distribution. In collaboration with other teams, this role will proactively review customer production forecasts, update capacity planning models and prepare customer-facing presentations for internal and external communication as required. Additionally, the Supply Chain Coordinator will oversee the purchasing responsibilities for select materials categories
What You Will DoParticipate in capacity planning activities across all departmentsMaintain and update customer forecasts working in conjunction with Business Development including the development of customer forecast accuracy metricsEnter and maintain sales order, ensuring clear communication across departments.Maintain and trend all Supply Chain related KPIsProduction planning and scheduling for consumable kits as requiredAssist in preparations of customer facing presentations related to inventory reporting and production planningProcess purchase requests following policy guidelines for select vendors.Proactively communicate with various AtomVie teams regarding status of their orders.Assist with month end activities as required.Assist in item and vendor on-boarding at AtomVie and creation in ERP system as requiredRecommend practices to ensure effectiveness and efficiency of strategic initiatives and inventory/warehouse management.Assist in the creation inventory strategies that minimize financial impact and recommend processes to manage materials Investigate and resolve inventory discrepancies in a timely mannerWork alongside purchasing to work within approved budget for all materials and productsDrive continuous improvement aligned with strategic initiatives and improve efficiency Handle the logistics and operations of the Warehouse as requiredComply with safety systems and policies and complete required radiation safety, GMP and TDG trainingPerform all other duties as assigned
What You Bring to the RoleExperience in a pharmaceutical manufacturing company is an assetStrong communication skills written and verbalAbility to work autonomously in a fast-paced environment and to adjust workload based on changing prioritiesFlexibility in hours to ensure production schedules are met and shipment of product is successfulA continuous improvement and quality-focused mindset.
RequirementsCertificate in supply chain or related disciplines or equivalent qualifications in business administration2-5 years’ experience supply chain, purchasing or warehouse/ distribution operationUnderstanding of WHMIS and SDSUnderstanding of Good Distribution and Good Warehousing PracticesWorking knowledge and understanding of GMP, OHSA, FDA, Health Canada guidelines as they apply to materials managementIn depth knowledge or warehouse operations, materials management, logistics and supply chain
AtomVie OffersGroup Health & Dental Benefits (from day 1)RRSP Matching ProgramPerkopolisEmployee Assistance and Wellness ProgramsParking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
Job DescriptionAtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the RoleThe Manufacturing Process Manager will coordinate the day-to-day operations of multiple production lines/shifts for programs. As Manufacturing Process Manager, you will assign tasks and adjust workloads to meet production schedules and plans, monitor training, assess the progress of the employees and oversee manufacturing quality and safety.
Reporting to the Director, Radiopharmaceutical Manufacturing, The Manufacturing Process Manager will also be responsible for overseeing the manufacturing operations efficiency through improvement projects implementation in collaboration with the Continuous Improvement manager, coordinating production plans with various departments in order to make sure that materials and other resources are in place to support production plan, and continuously monitoring and reporting results out of the shop floor.
What You Will DoEnsure consistent production of radiopharmaceuticals according to operational, quality, and safety requirements.Lead on production planning activities to include production scheduling, materials planning, and reporting.Act as point of contact for other departments and team members to coordinate matters related to manufacturing.Serve as leader for manufacturing related items, troubleshooting, and validations.Ensures that adequate staffing levels are maintained. Monitors overall training progress and reports the information to the Director of Radiopharmaceutical Manufacturing.Oversee and coordinate equipment calibration, maintenance and follows up on associated documentation.Systematically identifies facilities, equipment, utilities and processes that require improvements and ensures these improvements and/or investments are budgeted and effectively implemented.Maintains, edits and reviews manufacturing related standard operating procedures (SOP’s) and Master batch records (MBR’s). leading non-conformance investigations.Ensures that production department is in inspection ready state (GMP, Quality, Safety, HP) and participates in customer and regulatory or agency audits as required.Projects a professional and supportive demeanor while promoting safe and positive working environment.Support Business Development and Product Development teams regarding clients’ relationship when manufacturing inputs are of importance.Monitor and report production results against KPIs and efficiency metrics.Work alongside own supervisor to develop action plans for any decision-making on batch release and to troubleshoot and problem solve critical issues related to production.Inform Quality group of any production problems as well as any concerns with drug product quality immediately.Maintain documentation to fulfill all customer, facility, Provincial, Federal and applicable regulatory requirements relating to nuclear safety and cGMP manufacturing.Adhere to the Health Canada GMP requirements for sterile pharmaceuticals.Complete all other duties as required.
What You Bring to the Role You have experience in capacity planning and scheduling.Demonstrated success in managing and developing people in a GMP manufacturing environment.Ability to establish internal and external networks.You have excelled problem solving skills.Excellent planning, organizing, communication, and collaboration skillsKnowledge of materials management systems or ERP systems applications is a plus.You thrive in a fast-paced setting.
RequirementsDiploma/degree in Chemistry, Biology or related Science.5 - 10 years direct experience in pharma/biotech manufacturing organizations, including experience in aseptic GMP manufacturing industry.Minimum of two years of demonstrated leadership and behavioral competencies in a similar role.Experience in managing different aspects of GMP aseptic production is a must.Knowledge of GMP requirements and guidelines (mainly Health Canada, FDA, and EMA).Flexibility in work schedule to support a 24/7 production environment
AtomVie Offers Group Health & Dental Benefits (from day 1)RRSP Matching ProgramPerkopolisEmployee Assistance and Wellness ProgramsParking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
Job DescriptionAtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the RoleThe Facility & Maintenance Supervisor will be responsible for providing overall direction to the Facilities & Maintenance team in the everyday planning and execution of maintenance tasks. This role will also provide direction on the management of 3rd party contractors and work with other internal teams to ensure the site’s contracted services deliverables are executed safely, and efficiently.
The Facilities and Maintenance Supervisor role will support our new facility and establish the systems and business processes essential for GMP operations and site culture development. Success in this role will demand strong collaboration, innovation, and resilience as the site scales up to full GMP manufacturing during the startup phase.What You Will DoOversee and ensure timely completion of the master preventative maintenance schedule, all maintenance tickets and keeping activities up to date and on track. This includes tracking, scheduling and executing the maintenance work in coordination with the Area / Equipment owners across the site(s).Assign Facility and Maintenance tasks to technicians based on the production schedule/customer requirements and assure that employees are at maximum productivity.Coordinate and schedule the planned maintenance activities with the Area / Equipment owners across the site(s). Ensure AtomVie’s facilities are available, clean, maintained, & repaired to the applicable standards.Manage CMMS (Computerized Maintenance Management System) transition, asset management, develop and track maintenance KPI’s.Manage 3rd party vendors and a team of maintenance technicians to troubleshoot issues and perform necessary repairs or replacements of assets.Coordinate and manage contractors/suppliers by defining the scope of work, supervising tasks, and ensuring deliverables are completed as required. Contracted work may include HVAC and electrical maintenance, waste management, pest control, etc.Initiate, review and approve Work Permits as required.Initiate, review and approve annual contracts/renewals will 3rd party contractors.Perform hands-on execution of maintenance tasks, including timely troubleshooting, and correcting performance issues. Lead troubleshooting and repair of a wide range of complex equipment, such as shielded nuclear radiation containment chambers (hot cells), biological safety cabinets (BSCs), isolators, analytical and process equipment, addressing complex electrical, pneumatic and mechanical issuesMonitor and ensure spare parts, consumables, tools, and other equipment needed to maintain assets in optimal working condition are stocked as necessary.Diagnose and correct, on an on-call basis, operational problems as requiredPrepare/review and submit service/calibration reports for approvals and release.Ensure documentation completed in compliance with cGMPs, and AtomVie’s quality documentation. Follow AtomVie SOPs and procedures, support GMP documentation requirements to fulfill all Provincial and Federal regulatory requirementsEvaluate and analyze operating and maintenance records on an on-going basis, identifying problems and potential problem areas for improvement.Initiate and lead change controls and document changes in relation to the preventative maintenance program.Identify, initiate and drive process improvements in relation to the preventative maintenance program.Provide Management with reports related to equipment performance and recommendations related to improvements. Implement modifications to increase performance and reliability as approved by Management.Participate and engage in training provided by AtomVie via consultants or third-party groups for continuous improvement within this role.Prepare and lead the training for new maintenance team hires in relation to the maintenance program – This will include the hands-on training and supporting the new hire with documentation training.Ensures compliance with Health Physics, Health, Safety and Environment protection rules, with engagement of all associates to apply the policies, procedures and regulations applicable to their work.Demonstrate safety knowledge, awareness and compliance with all safety and other job-related policies and procedures.What You Bring to the RolePassion for driving continuous improvements in processes, efficiency, and overall performance through innovative solutions and data-driven strategiesStrong technical experience in troubleshooting and repair of complex technical systems (example: electronic, computing, pneumatic and electro-mechanical, automation systems).Experience in reading and understanding complex electronic and pneumatic drawingsPrevious experience leading a team of direct reports Thrives in a fast-paced setting.Ability to work independently and possess excellent organizational skills.Highly motivated with strong attention to detail
RequirementsA College Diploma/degree in a technical field (Mechanical, electrical, etc.) or relevant experience.Minimum five (5) years of pharmaceutical GMP manufacturing experience, managing a Facility or Maintenance Team.Three (3) years in a supervisory roleGMP experience is a must requirement. Demonstrated ability to successfully prioritize, manage time well, multitask, and troubleshoot.Flexibility and willingness to work weekends, holidays and support on-call 24/7 (rotating schedule).Previous experience in facility/area start-up environments is an Asset.Willingness to work fluctuating start times to meet business needs.Excellent verbal and written communication skills, with expertise in technical report writing and a strong ability to understand and analyze complex systems and trends.Must be able to withstand exposure to temperature variations while performing work outside in winter and summer weather conditions.You will be trained as a Nuclear Energy Worker (NEW). Ability to lift 50lbs, crawl, stoop, crouch, and kneel in small spaces.Other related duties, as required.
AtomVie OffersGroup Health & Dental Benefits (from day 1)RRSP Matching ProgramPerkopolisEmployee Assistance and Wellness ProgramsParking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
