Quality/ Validation Engineer

In which structure will you work as a Qualification & Validation Engineer?

We are looking for a Qualification & Validation Engineer for one of our clients, based in Toulouse.

 
Qualification & Validation Engineer: What will your missions and responsibilities be?

Role objective

Lead and execute qualification and validation activities for equipment, sterilization processes, and environmental control within technical and regulatory projects on a GMP site, ensuring compliance with international requirements (GMP, Annex 1, FDA, ICH Q9/Q10).
 
Main responsibilities

Strategy & planning

• Define the global qualification and validation strategy (Validation Master Plan), covering Biotech, QC, sterilization, and environmental control.
• Establish IQ/OQ/PQ qualification plans and integrate the Cycle of Development (COD) for critical equipment.
• Define acceptance criteria, sampling protocols, and monitoring strategies (residues, contamination, equipment performance).

Documentation & execution

• Draft and execute IQ/OQ/PQ protocols and reports for:

• Sterilization equipment: autoclaves, sterilization cycles, SIP.
• Biotech equipment: bioreactors, chromatography skids, filtration systems.
• QC equipment: HPLC, GC, ICP-OES, spectrophotometry.
• Environmental control: EMPQ qualification, disinfection studies, particulate and microbiological monitoring.

• Update and manage related documentation in the electronic quality system (eQMS).

Deviation & change management

• Handle non-conformities (NC) and follow up on change requests (CR) related to validation activities.
• Implement and monitor corresponding CAPAs.

Collaboration & support

• Work closely with Quality, Production, Metrology, and Project teams.
• Prepare and defend files during internal audits and regulatory inspections.
• Train or support operational teams in qualification and validation best practices.

 

What profile and skills are required for this Qualification & Validation Engineer position?

• Education: Master’s degree (Bac+5) in pharmacy, biotechnology, chemistry, or process engineering.
• Experience: Minimum 4 years of experience in qualification/validation in the pharmaceutical or biotechnology industry.
• Skills:

Significant experience (≥ 4 years) in qualification/validation in a GMP pharmaceutical environment.
Strong knowledge of regulatory frameworks (GMP, FDA, EMA).

• Technical expertise in:

Autoclave PQ / cycle development
EMPQ and disinfection studies
Qualification of QC and Biotech equipment (bioreactor, chromatography skid, filtration)
Proficiency in technical English (technical discussions, documentation writing).
Autonomy, rigor, analytical skills, and strong interpersonal abilities.
Professional English (written and spoken).

• Salary & benefits: Based on profile.

 
Interested in this position? Send us your application!

EP2C Energy is committed to diversity and inclusion. We encourage applications from individuals recognized as workers with disabilities.

As part of our Quality, Health, Safety & Environment (QHSE) policy, we place the highest importance on compliance with QHSE rules to ensure a safe working environment for our employees, with the ambition of contributing positively to the environment.

Our company is engaged in continuous improvement through its Quality Management System (QMS) and its Health, Safety & Environment Management System (HSEMS).

By joining our teams, you will be expected to follow HSE procedures and best practices while contributing to the continuous improvement of our processes.