Validation Engineer

PQE Group, a leader in the Pharmaceutical and Medical Device industries, is seeking a Validation Engineer for a 3-month renewable contract at our Lure site.

Key Responsibilities

• Track the progress of the master validation plan, providing effective reporting and managing performance indicators.
• Conduct and write process risk analyses to define critical attributes for product quality and critical parameters for process execution.
• Draft validation documents (Validation Master Plan, validation protocols, test sheets, validation reports, etc.) in compliance with procedures.
• Plan and manage testing activities.
• Monitor production batches and perform sampling as needed.
• Analyze results, address any non-conformities, and propose corrective action plans to resolve deviations.
• Ensure proper traceability management for validation interventions.
• Collaborate with the validation team to manage activities according to the project deliverable schedule, ensuring timely submission of all documents.

About You

• Engineer/Client 5 (or equivalent) with previous experience in process validation on one or more pharmaceutical manufacturing sites.
• Experience that allows you to work independently on the tasks assigned.
• Familiarity with Good Manufacturing Practices (GMP) and French regulations related to validation.
• Strong communication skills and the ability to work collaboratively with multiple teams involved in complex validation processes (process development, production, planning, QC lab).
• A hands‑on approach and strong team spirit are essential to carry out the tasks effectively.

Specific Requirements

• This mission will be performed on‑site in Lure, with the possibility of occasional remote work based on task requirements.
• Flexibility in working hours (2x8 shifts) may be required occasionally.
• Accessibility: The Lure site is not easily accessible by public transportation.
• Allergies: Please note any beta‑lactam allergy.