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Added 4 months ago
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Substation Electrical Engineering Team Lead
Stantec
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- Full-time
Ensure client expectations related to project scope are clearly understood, met, and exceeded.
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Facility Manager
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- Full-time
Project Management roles to lead and execute projects,
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- Full-time
Project management, Change Management and Vendor Management experience (ie. managing outsourced learning program providers), an asset.
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Provide project management and technical oversight of other engineers for multiple projects. Responsible for overseeing the work and managing development of other Engineers and…
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Continuous Improvement & Lean Manufacturing Lead
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Digital Consulting Director-Oracle EPM Planning (Bilingual French and English)
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- Full-time
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Senior Financial Analyst, Policy Tax
THE EMPIRE LIFE INS. CO
Canada
- Full-time
Act as a subject matter expert for the annual year-end tax process and support tax-related system changes
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Remediation Engineer
Pinchin in Canada
Mississauga, Ontario · Oshawa, Ontario · Toronto, Ontario
- $80,000 to $110,000 CAD / year
- Full-time
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Project Manager
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Your strong attention to detail and expert organizational abilities will have a significant and visible effect on the success of projects. You will act as the primary point of contact,…
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Environmental Director - Canada West
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Remote, Canada
- Full-time
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Circuit Delayering Specialist
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Communicate clearly with the Image Processing, Circuit Engineering, and Management teams to ensure sample and image quality needs are met throughout each project
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Technical Architect, Microsoft D365 F&SCM - Canada
Huron
Remote, Canada
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Added 4 months ago
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Manager, CQV
API
Edmonton, Alberta
- Full-time
- Temporary
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…
Added 4 months ago
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Atkore
Ontario
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Must be able to demonstrate proficiency in time and project management.
Added 4 months ago
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Added 1 month ago
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API

Manager, CQV

Edmonton, AB, T6N 1H1, Canada

Full-time · Temporary

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Job details

Job type: Full-time · Temporary
Posting language: English
Posted: Jun 8, 2026

Original job description

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. 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.

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 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 careers@appliedpharma.ca.

Our team, clients, and stakeholders come from a variety of backgrounds. In 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.

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More about this job

Responsibilities

Serve as the Subject Matter Expert for the CMPC project, overseeing complex construction, installation, and CQV activities for a pharmaceutical manufacturing facility. Lead the preparation and execution of qualification protocols (IQ/OQ/PQ) and ensure compliance with GMP and safety standards.

Requirements

Requires a Bachelor's or Master's degree in an engineering-related science and a current Professional Engineer (PEng) license. Candidates need 5+ years of experience in process or manufacturing engineering, preferably within the pharmaceutical industry with expertise in sterile filling lines.

Skills

Commissioning Qualification and Validation
Project Management
GMP Compliance
Risk Assessment
Cleanroom Installation
Aseptic Process Support
Computer System Validation
Technical Leadership
Mechanical Design
Manufacturing Engineering
BMS Qualification
SAT Execution
IQ OQ PQ Protocols
FMEA
Stakeholder Management
CAE/CAM

Benefits

Comprehensive Health Coverage
RRSP Matching Program
Professional Development Opportunities
Paid Time Off
Green Transit Allowance
Work From Home Days

Visa sponsorship

Not detected in the job text

Keywords

CQV
GMP
Pharmaceutical
PEng
Aseptic Fill
Small-Molecule
BMS
GAMP 5
FMEA
URS
SAT
IQ
OQ
PQ
Cleanroom
CSV
Life Sciences
Mechanical Engineering
Process Engineering
Data Integrity
CAE
CAM
CMPC
CCDI

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