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.

We are seeking a Manager, CQV (Installation, Commissioning, Qualification and Validation). 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, aiming to establish an integrated research, commercialization, and manufacturing cluster in the Edmonton Metropolitan Region.

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.

This is a full‑time temporary contract with an expected end date on December 2027. Please note this position requires full‑time on‑site presence.

Key Responsibilities, Include But Are Not Limited To





Subject Matter Expertise & Technical Leadership

- Serve as the Subject Matter Expert (SME) for the CMPC‑project on all matters related to complex construction, installation, and CQV activities, providing technical guidance and ensuring alignment with project design requirements.

Project Collaboration & Technical Support

- Work closely with the Project Manager to solve open technical issues.
- Assist the API Project Manager and project team in addressing requests for information in a timely manner.
- Attend internal and external meetings throughout the project and give input for complex construction and CQV activities.

Construction Oversight & Execution

- Direct and control complex construction activities like Clean‑Room installation, together with utility systems and complex equipment for GMP‑manufacturing.
- Review construction QA/QC activities and elevate deficiencies.

Commissioning Management & Oversight

- Review commissioning schedules, plans, check‑lists and reviews.
- Review with the construction manager and commissioning authority commissioning plans and give input for complex building and process systems.
- Oversight of commissioning execution.
- Collect documentation from QA/QC and commissioning of the construction company.




- Review commissioning reports.

Qualification & Validation (CQV) Activities

- Assist the Equipment Engineering Manager in qualification activities.
- Prepare IQ and OQ protocols together with the Equipment Qualification Manager.
- Perform IQ and OQ on site in collaboration with the Equipment Engineering Manager, develop and review the corresponding IQ and OQ reports.
- Prepare PQ plans and protocols together with the Technical Operations team.

System Qualification & Testing

- Qualify complex pharmaceutical air systems and Building Management Systems (BMS).
- Review SAT protocols and ensure readiness, including necessary connection with utilities.
- Perform Site Acceptance Tests (SATs) in collaboration with the Equipment Suppliers and Engineering Managers.

Risk Management & Compliance

- Compile and review GMP, FMEA based risk‑assessment for new equipment and processes.

Cleanroom & Aseptic Process Support

- Assist in qualification of clean rooms (e.g. smoke studies).
- Assist in media‑fill plans and reports.

CSV & IT Systems Support

- Assist the CSV‑Manager and IT‑Manager in the oversight of the commissioning and qualification of the complex IT‑Infrastructure.
- Assist in CSV (computer system validation) activities for equipment and new IT systems.

Qualifications - (Education, Certification, Degree, Skills, Knowledge, Etc.)

Education

- A Bachelor’s or Master’s degree in an engineering‑related science discipline.
- Current Qualified Engineer (PEng) license, required.

Experience

- 5+ years of experience with process, mechanical design

📌 Manager, CQV (Edmonton)
🏢 API (Applied Pharmaceutical Innovation)
📍 Edmonton