Negotiable
Undetermined
Undetermined
England, United Kingdom
Summary: Eblex Group is seeking experienced CQV Engineers/Consultants for a new greenfield CMO facility in the UK. The role involves supporting the commissioning, qualification, and validation of a state-of-the-art manufacturing site, with responsibilities spanning from early-stage build to GMP manufacturing. Candidates should have a strong background in CQV within pharmaceutical or biotech environments and be adept at working in fast-paced project settings.
Key Responsibilities:
- Execute Commissioning, Qualification, and Validation (CQV) activities across facility, utilities, and equipment
- Support development and execution of IQ/OQ/PQ protocols
- Lead qualification of clean utilities, HVAC systems, and process equipment
- Ensure all activities align with GMP and regulatory requirements
- Work closely with Engineering, Quality, and Project teams to meet key project milestones
- Support documentation, deviation management, and validation lifecycle activities
Key Skills:
- Proven experience in CQV within pharmaceutical, biotech, or CMO environments
- Strong background in greenfield or large-scale facility build projects
- Experience with clean utilities, HVAC, and GMP manufacturing equipment
- Strong understanding of EU GMP, Annex 1, and validation principles
- Ability to operate in a fast-paced, project-driven environment
- Excellent documentation and stakeholder coordination skills
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Eblex Group is supporting a new greenfield CMO facility build in the UK and is seeking experienced CQV Engineers / Consultants to support the commissioning, qualification, and validation of a state-of-the-art manufacturing site. This is a high-impact contract opportunity to be involved from early-stage build through to facility readiness and GMP manufacturing, working on complex systems in a fast-paced project environment.
Scope of Work for the CQV Engineer
- Execute Commissioning, Qualification, and Validation (CQV) activities across facility, utilities, and equipment
- Support development and execution of IQ/OQ/PQ protocols
- Lead qualification of clean utilities, HVAC systems, and process equipment
- Ensure all activities align with GMP and regulatory requirements
- Work closely with Engineering, Quality, and Project teams to meet key project milestones
- Support documentation, deviation management, and validation lifecycle activities
What We’re Looking For in a CQV Engineer
- Proven experience in CQV within pharmaceutical, biotech, or CMO environments
- Strong background in greenfield or large-scale facility build projects
- Experience with clean utilities, HVAC, and GMP manufacturing equipment
- Strong understanding of EU GMP, Annex 1, and validation principles
- Ability to operate in a fast-paced, project-driven environment
- Excellent documentation and stakeholder coordination skills
Application
This search is being conducted by Eblex Group . For confidential consideration, please apply directly or contact Eblex Group to learn more about the opportunity.