Technical Lead - Validation Support

Sauveterre-de-Guyenne , Nouvelle-Aquitaine, France

Type: n/a

Category: Customer Service & Support

Requirements: English
Company: PQE Group
Region: Sauveterre-de-Guyenne , Nouvelle-Aquitaine

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas.

Due to our continuous growth, we are currently seeking an experienced Technical Lead - Validation Support. The ideal candidate will have a strong background in validation within GMP-regulated environments and will work closely with local stakeholders to ensure timely and compliant execution of validation-related activities.

Key Responsibilities:

• Manage and execute validation of manufacturing equipment, with a focus on addressing the current backlog of periodic inspections.
• Support the validation of Operational Technology (OT) infrastructure, including the migration of analytics and equipment from IT to OT environments.
• Provide project leadership and validation support for the planned implementation of PCS7 as a Distributed Control System (DCS).
• Coordinate with cross-functional teams and local stakeholders, conducting meetings and discussions.
• Prepare and maintain Commissioning, Qualification, and Validation (CQV) documentation in English, ensuring compliance with regulatory requirements.

Qualifications:

• Proven experience in validation engineering or CQV project management in pharmaceutical or biotech manufacturing environments.
• Solid understanding of GMP regulations, validation protocols, and documentation best practices.
• Strong knowledge of OT/IT systems, data integrity principles, and automation systems such as PCS7.
• Languages: Fluency in French and English
• Excellent interpersonal and communication skills.
• Ability to manage multiple priorities and drive tasks to completion within deadlines.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there''s a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.

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