Validation / Quality Engineering

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?

Context

As part of a biopharmaceutical production equipment duplication project, the Qualification & Validation (Q&V) Engineer will provide operational and documentation support to the team in charge of validation and regulatory compliance activities.

Main responsibilities

Documentation drafting, review, and approval:

• Qualifications (IOQ, PQ)
• Validation protocols and reports
• User Requirements Specifications (URS)
• System Impact Assessments, Data Integrity Assessments
• Risk analyses (criticality, requirements traceability)
• Validation Summary Reports

Operational support:

• Participation in daily and planning meetings (Pull Planning)
• Management of deviations and non-conformities (discrepancy management)
• Contribution to changes (change control, project change notices)
• Support in protocol execution in the field when required
• Follow-up of preventive maintenance and system calibrations
• Equipment labeling and traceability

Communication & coordination:

• Representing the Q&V team in project meetings
• Regular monitoring and reporting on activity progress

 

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

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

Strong experience in GMP equipment qualification and validation in the pharmaceutical or biotechnology industry
Proficiency in regulatory documentation (GMP, GAMP 5, Data Integrity)
Knowledge of biopharmaceutical production equipment: balances, bioreactors, chromatography skids, column preparation systems, etc.
Strong documentation rigor, analytical mindset, and deviation management skills
Strong communication skills and ability to represent the Q&V team to project partners
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.