Manager, CQV

API • Edmonton, AB

3d • Onsite

About The Position

Applied Pharmaceutical Innovation (API) is seeking a Manager, CQV (Installation, Commissioning, Qualification and Validation) to join one of its most important projects, the Canadian Critical Drug Initiative (CCDI). The CCDI aims to establish an integrated research, commercialization, and manufacturing cluster in the Edmonton Metropolitan Region. A key component of this project is the Critical Medicines Production Centre (CMPC), an 83,000+ square-foot manufacturing facility focused on producing small-molecule product solutions, conducting sterile, aseptic fill, and finishing traditional and biologic drugs to meet drug shortages needs. This position requires full-time on-site presence.

Requirements

• A Bachelor's or Master's degree in an engineering-related science discipline.
• Current Professional Engineer (PEng) license, required.
• 5 + years of experience with process, mechanical design and/or manufacturing engineering experience, preferably in the pharmaceutical industry.
• Proven work experience in process and/or mechanical and/or electrical and/or qualification engineering.
• Excellent technical skills and knowledge of process related standards.
• Familiarity with health and safety regulations.
• Prepared User Requirement Specifications (URS) and related documentation for process equipment and utilities.
• Familiarity with Data Management - Integrity and Records.
• Extensive knowledge and applied experience in project management principles.
• Demonstrated ability to organize and manage full range of project work, from small details to the big picture, with competing priorities.
• Demonstrated leadership, team building, and relationship management.
• Exceptional communication and interpersonal skills, with the ability to interact with stakeholders at all levels.
• Strong leadership and team management skills, with the ability to motivate and guide teams toward project success.
• Excellent organizational, planning, and prioritization skills.
• Analytical problem-solving and clear communication skills.
• Relationship building, influencing, advocating, and negotiating capabilities.
• Excellent attention to detail, written communication and interpersonal skills.
• Effective in a fast-paced start-up environment.
• Proactive, analytical, results-oriented, and creative.
• Fosters transparent, honest, and positive team environment.
• Results-driven and process-oriented.
• Comfort with ambiguity and cultural differences.
• Required travel between Edmonton API sites.
• This position requires you to be on site and at the construction site.
• Maybe required to travel to several worldwide locations of vendors/suppliers especially Canada, USA and Europe.
• Exposure to chemicals, machinery and equipment and requirement to wear PPE.
• Ability to safely perform site visits and inspections, including walking on uneven terrain, climbing stairs/ladders, standing/walking for extended periods, and occasional lifting.
• Applications submitted without a resume AND cover letter will not be reviewed.
• Proof of a P.Eng. designation required.
• 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.

Nice To Haves

• Experience with sterile filling line installation, commissioning and qualification is considered a strong asset.
• Experience working in pharmaceutical industry construction activities is preferred.
• Experience over a wide range of pharmaceutical equipment preferred.
• Experience in validating pharmaceutical air systems and Building Management Systems (BMS), preferred.
• Experience with GAMP 5 practices (Good Automated Manufacturing Practices V), preferred.
• Proficient with computer-aided engineering (CAE) and computer-aided manufacturing (CAM), preferred.

Responsibilities

• Serve as the Subject Matter Expert (SME) for CMPC-project on all matters related to complex construction, installation, and CQV activities, providing technical guidance and ensuring alignment with project design requirements.
• 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.
• 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 escalate deficiencies.
• 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.
• 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.
• Qualifying 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.
• Compile and review GMP, FMEA based risk-assessment for new equipment and processes.
• Assist in Qualification of Clean rooms (e.g. smoke studies).
• Assist in Media-fill plans and reports.
• 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.

Benefits

• Comprehensive health coverage plan with 100% premium coverage for employees and dependents.
• RRSP Matching Program with API matching contributions up to 1-3% of base salary.
• Access to professional development opportunities including training programs, workshops, conferences, and certifications.
• Collaborative and inclusive work environment.
• Generous paid time off (PTO) policy including vacation days, medical/personal days, and holidays.
• Green Transit Allowance for eligible employees.
• 20 Work From Home days for eligible employees, subject to job function, company needs, and manager approval.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager