CQV Consultant: GMP Commissioning & Validation Lead

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

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.