CQV engineer - US and Canada

Project Delivery Partners

94d

About The Position

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.

Requirements

• 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.

Nice To Haves

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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees