CQV Consultant
CQV Consultant (Contract)
Location: Lyon Region, France (On-site)
Contract Length: 12 Months
Industry: Pharmaceuticals
Start Date: ASAP
The Opportunity
We are supporting a leading pharmaceutical manufacturing site undergoing a significant capital investment and expansion programme. As part of this project, we are seeking an experienced CQV Consultant to support Commissioning, Qualification & Validation activities across GMP manufacturing equipment, utilities and process systems.
This is a hands-on role requiring strong experience within regulated pharmaceutical, biotech or CDMO environments.
Key Responsibilities
- Execute Commissioning, Qualification & Validation activities in line with GMP requirements
- Develop and review qualification documentation including IQ, OQ and PQ protocols
- Coordinate FAT and SAT activities with equipment vendors
- Perform equipment risk assessments and impact assessments
- Support deviation investigations and change controls related to qualification activities
- Ensure qualification activities comply with site validation master plans and regulatory expectations
- Liaise with Engineering, Manufacturing, QA and external suppliers throughout the project lifecycle
- Drive project timelines and ensure milestones are achieved
Requirements
- 5+ years' experience within CQV, Validation or Qualification roles in GMP-regulated environments
- Pharmaceutical, biotechnology or CDMO manufacturing experience
- Proven experience executing IQ/OQ/PQ activities
- Experience supporting commissioning and start-up activities
- Strong understanding of GMP, GDP and validation lifecycle principles
- Ability to work independently in a fast-paced project environment
- Fluent English required; French language skills are advantageous
Highly Desirable Experience
- Fill & Finish manufacturing
- Sterile production environments
- Isolators
- Lyophilizers
- Autoclaves
- Clean utilities qualification
- Water Systems (PW/WFI)
- Clean Steam
- HVAC qualification
- Annex 1 projects
- New facility or expansion projects
What We're Looking For
We're particularly interested in consultants who have successfully delivered qualification packages from commissioning through to PQ and can confidently operate as a subject matter expert within multidisciplinary project teams.
This is an excellent opportunity to join a long-term project with a leading pharmaceutical manufacturer and play a key role in delivering critical manufacturing capacity.
If you have strong CQV experience within pharma, biotech or CDMO environments, apply today to discuss the project in more detail.
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