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. It aims 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.
** 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 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 escalate deficiencies
Commissioning Management & Oversight
- Review commissioning schedules, plans, check list 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
- 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
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 Professional Engineer (PEng) license, required.
Experience:
- 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
- Experience with sterile filling line installation, commissioning and qualification is considered a strong asset
- 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.
- 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.
Personal Competencies
- 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
Working Conditions:
- 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 preform site visits and inspections, including walking on uneven terrain, climbing stairs/ladders, stranding/walking for extended periods, and occasional lifting.
Additional Required Documents to Support Application
- Applications submitted without a resume AND cover letter will not be reviewed.
- Proof of a P.Eng. designation required.
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 1-3% 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 everyone's 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 [redacted].
This position will remain open until filled.
