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 Canadas life sciences sector.

You will be part of one of APIs 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 83000 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 Canadas largest and best equipped of its kind. The CMPCs 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 Bachelors 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 ensuring that you and your dependents receive the necessary healthcare support.

Retirement Savings: API offers a RRSP Matching Program. Employees may be eligible to participate with API matching of contributions up to 13% of base salary in accordance with program terms.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities including training programs workshops conferences and certifications. We encourage employees to enhance their skills broaden their knowledge and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork open communication and a supportive atmosphere where everyones contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days medical/personal days and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program which promotes the use of environmentally friendly modes of transportation. By participating in the program you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking biking carpooling and public transportation.

Work From Home: Eligible employees are entitled to 20 Work from Home days this is subject to job function company needs and manager approval.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants interest and will only contact those selected for interviews.

If you have any questions about the application process or require accommodations during the hiring process please contact .

Our team clients and stakeholders come from a variety of recruiting for our team we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences education culture gender race sexual orientation religious or ethnic background neurodiversity and cognitive and physical ability.

Before employment successful candidates will be required to meet the requirements of a pre-employment screening which includes background reference checks educational credential verification and criminal reference checks.

This position will remain open until filled.

Required Experience:

IC