CQV Consultant

EPM Scientific; Lyon; On-site; EUR 83,000 - 148,000; Full time

Job summary

EPM Scientific is supporting a leading pharmaceutical manufacturer in the Lyon region with a 12-month on-site CQV Consultant contract. The role covers commissioning, qualification and validation across GMP equipment, utilities and process systems.

The successful candidate will develop IQ/OQ/PQ protocols, coordinate FAT/SAT with vendors, perform risk assessments and support deviations and change controls, ensuring alignment with validation master plans and regulatory expectations.

Qualifications

• 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

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

Skills

CQV experience

GMP environment

IQ/OQ/PQ

Regulatory compliance

Independent worker

Job description

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.

CQV Consultant (Contract)

Location: Lyon Region, France (On-site)
Contract Length: 12 Months
Industry: Pharmaceuticals
Start Date: ASAP

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.