Production Operator

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven, compassionate, and laser focused on making a dramatic positive impact with everything we undertake.
When you join API, you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries, increasing the amount of commercial research and development in the country, and supporting Alberta as a key pillar in Canada’s life sciences sector.
You will be part of one of API's most important projects, the Canadian Critical Drug Initiative (CCDI). The CCDI is a project led by API in partnership with the University of Alberta. It aims to establish an integrated research, commercialization, and manufacturing cluster in the Edmonton Metropolitan Region.
One aspect of the project involves upgrading the Biotechnology Business Development Centre (BBDC) in the Edmonton Research Park. The upgrade will include GMP-certified manufacturing suites for API-manufacturing, chemical-physical testing, and Health Canada-approved warehousing capacity.
The second part of the project is the Critical Medicines Production Centre (CMPC), which will be a new 83,000+ square-foot manufacturing facility located on a 7-acre plot of land in the center of the Edmonton Research Park. This facility is set to be Canada’s largest and best equipped of its kind. The CMPC's focus will be on producing small-molecule product solutions, conducting sterile, aseptic fill, and finishing traditional and biologic drugs to meet drug shortages needs.
The Production Operator performs manufacturing activities for active pharmaceutical ingredient (API) production in accordance with approved batch records, standard operating procedures (SOPs), current Good Manufacturing Practices (cGMP), environmental, health and safety requirements, and company quality standards. The role supports safe, compliant, and efficient execution of chemical processing, equipment operation, material handling, cleaning, and manufacturing documentation.
** Please note this position requires full-time on-site presence.
Key Responsibilities, include but are not limited to:
Manufacturing Operations
Execute assigned manufacturing operations according to approved batch production records, SOPs, work instructions, and safety procedures.
Operate, monitor, and clean API production equipment, including reactors, filter dryers, centrifuges, dryers, mills, blenders, vacuum systems, transfer systems, and associated utilities, as applicable.
Perform chemical charging, dispensing, weighing, solution preparation, reaction processing, filtration, washing, drying, milling, blending, and packaging activities.
Verify raw materials, intermediates, solvents, labels, quantities, equipment status, and line clearance requirements before use.
Monitor critical process parameters such as temperature, pressure, vacuum, agitation speed, flow rate, pH, nitrogen purge, reaction time, and equipment operating conditions; promptly report abnormalities.
Collect in-process samples or support sampling activities in accordance with approved procedures and coordinate sample submission to Quality Control, where assigned.
Perform routine in-process checks, including visual inspections, weight verification, pH checks, moisture testing, sieve checks, and yield calculations, as applicable.
GMP and Quality Expectations
Follow cGMP principles, data-integrity requirements, and good documentation practices at all times.
Record information contemporaneously, accurately, legibly, and completely; never backdate, overwrite, or obscure manufacturing data.
Escalate any actual or potential impact to product quality, patient safety, data integrity, or regulatory compliance without delay.
Ensure only approved, in-date, and properly identified materials, documents, and equipment are used.
Maintain compliance with established cleaning, line clearance, status-control, and contamination-control requirements.
Documentation & Compliance
Accurately complete batch records, equipment logbooks, cleaning records, labels, material reconciliation records, and other controlled manufacturing documentation in real time.
Follow established controls for material identification, status labeling, traceability, segregation, and prevention of mix-ups or cross-contamination.
Identify and immediately report deviations, equipment malfunctions, unsafe conditions, spills, documentation errors, and potential quality concerns to the Supervisor or designated representative.
Support deviation investigations, corrective and preventive actions (CAPA), change controls, and continuous-improvement activities by providing timely and accurate operational information.
Equipment Operations & Maintenance
Conduct equipment assembly, disassembly, changeover, cleaning, and preparation activities in accordance with validated cleaning procedures.
Maintain production rooms, equipment, and controlled areas in a clean, orderly, and inspection-ready condition.
Perform cleaning of facility and work surface as per approved procedures.
Participate in routine equipment checks, basic troubleshooting, preventive maintenance support, and communication with Maintenance, Engineering, Quality Assurance, and EHS teams.
Safety, Quality & Environmental Compliance
Follow gowning, hygiene, containment, PPE, and controlled-area entry requirements appropriate to the manufacturing operation and material hazard classification.
Safely handle hazardous chemicals, solvents, potent compounds, combustible materials, and process waste in accordance with site EHS procedures, SDS requirements, and applicable regulations.
Materials & Inventory Management
Assist with inventory control, material staging, waste management, and reconciliation of starting materials, intermediates, solvents, and finished API.
Validation, Training & Continuous Improvement
Support technology transfer, scale-up, validation, process performance qualification, cleaning validation, and engineering batch activities when assigned.
Attend required GMP, EHS, technical, and job-specific training; maintain qualification status for assigned tasks and equipment.
Participate in shift handovers and communicate production status, open issues, safety observations, and priority activities clearly to incoming personnel and supervision.
Additional Duties
Perform other production-related duties as assigned by the Production Supervisor or Manager.
Qualifications - (Education, Certification, Degree, Skills, Knowledge, etc.)
Education
Minimum of Bachelor’s of Science in Chemistry, Life Science or related field.
Experience:
3 plus years of experience in the related field is required.
Previous experience in API manufacturing, Pharmaceutical, Chemical, Biotechnology or other regulated manufacturing environment is preferred.
Familiarity with cGMP, SOP adherence, Controlled documentation, and safe handling of chemicals is preferred.
Personal Competencies
Strong oral and written communication.
Ability to follow detailed written instructions, perform basic calculations, and accurately complete production documentation.
Good interpersonal skills with the ability to interact with people at all levels with sensitivity and tact.
Mathematical ability, e.g., decimals, addition, subtraction, problem-solving
Working Conditions:
Required travel between Edmonton API sites.
This position requires you to be on site.
Ability to work rotating shifts.
Wear personal protective equipment including full face respirator.
Perform physical tasks such as Lifting/pushing/pulling up to 25lb, standing for extended periods, and working in controlled environments.
Direct contact with alcohol/chlorine based disinfectant agents.
Strong attention to detail, safety awareness, teamwork, communication, and problem-solving skills.
Additional Required Documents to Support Application
Applications submitted without a resume AND cover letter will not be reviewed.
Perks and Benefits at API
Comprehensive Health Coverage: At API, we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered, ensu

Employment type
Full-Time (Permanent)

Work arrangement
No