CQV engineer - US and Canada

Job Title: CQV Engineer (Jun - Mid - Senior Level)
Location: North America (Canada and U.S.A)
Industry: Pharmaceutical / Biotech Manufacturing
Employment Type: Full-Time or Contract

Position Summary

We are seeking a jun -, mid- to senior-level Commissioning, Qualification & Validation (CQV) Engineer to support project execution in pharmaceutical and biotech manufacturing facilities. This role is field-based and execution-oriented, focused on delivering commissioning, qualification, and validation activities across multiple systems and equipment.

The ideal candidate will have solid hands-on experience in GMP-regulated environments, with proven expertise in supporting CQV deliverables for utilities, process equipment, and/or manufacturing systems.

Key Responsibilities

• Support the preparation, execution, and review of commissioning, qualification (IQ/OQ), and validation protocols.
• Perform walkdowns, verifications, functional testing, and support equipment/system handover.
• Participate in FAT/SAT, installation verification, punchlist management, and issue resolution.
• Develop turnover packages (TOPs), traceability matrices, and associated documentation.
• Collaborate with QA, Automation, Engineering, and Construction teams to ensure delivery per GMP and project standards.
• Document and escalate deviations, supporting investigation, resolution, and closeout.
• Ensure compliance with cGMP, ASTM E2500, and risk-based CQV methodologies.

Systems in Scope (examples)

• Utilities: Purified water, WFI, clean steam, HVAC, compressed air and gases, CIP/SIP.
• Process Equipment: Bioreactors, filtration systems, chromatography skids, formulation tanks, centrifuges, filling and packaging equipment.
• Support Systems: Automation platforms (DeltaV, SCADA, BMS), cleaning systems, lab or analytical equipment.

Qualifications

• Bachelors degree in Engineering, Life Sciences, or related technical field.
• 5+ years of experience in CQV within GMP-regulated facilities (pharmaceutical or biotech).
• Strong knowledge of utilities, process equipment, or manufacturing systems.
• Proficiency with Kneat or other electronic validation tools.
• Ability to read and interpret P&IDs, engineering drawings, and technical documentation.
• Strong understanding of cGMP requirements, validation practices, and risk-based approaches.
• Excellent communication, organization, and technical writing skills.
• Team-oriented with the ability to work in cross-functional, fast-paced environments.

Preferred Experience

• Participation in greenfield, brownfield, or expansion projects.
• Familiarity with automation and building management systems.
• Experience using commissioning tracking tools or turnover documentation systems.

About Efor Group

Efor Group | The Global Leader in Life Science Compliance Engineering

Founded in 2013, Efor Group is today the world leader in compliance engineering for the Life Sciences industry. We support pharmaceutical, biotech, and medtech companies in securing production compliance and accelerating the market launch of safe and effective drugs, vaccines, and medical devices.

With 3,200 experts across three continents, Efor delivers recognized excellence in quality engineering and regulatory compliance to the worlds largest healthcare players.

Our mission is clear: to remove technical and regulatory barriers so that innovation turns into accessible therapiesfaster, safer, and worldwide.

Ready to transform healthcare with us? Join the journey.
www.efor-group.com