Validation Engineer

PQE Group; Lure; Sur place; EUR 40 000 - 55 000; Plein temps

Résumé du poste

A leading pharmaceutical company is seeking a Validation Engineer for a 3-month renewable contract in Lure, France. The successful candidate will track validation plans and conduct risk analyses, ensuring compliance with Good Manufacturing Practices and French regulations. Strong communication and collaboration skills are essential. This on-site role may allow for occasional remote work but requires flexibility in hours due to operational needs. Experience in pharmaceutical manufacturing is preferred.

Qualifications

• This role requires previous experience in process validation in pharmaceutical manufacturing.
• Must have familiarity with French regulations related to validation.
• Ability to work independently on tasks assigned.

Responsabilités

• Track and report on the master validation plan progress.
• Conduct process risk analyses and draft validation documents.
• Plan and manage testing activities and monitor production.
• Propose corrective action plans for any non-conformities.

Connaissances

Process validation

Communication skills

Collaboration

Good Manufacturing Practices (GMP)

Formation

Engineering degree or equivalent

Description du poste

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.