Validation Engineer (M/F)

Peters Surgical, a French company, develops, produces, and markets sterile single-use medical devices for the operating room, designed for surgeons. As a European leader in medical devices, we have over 765 employees worldwide. Our international presence allows us to distribute our products in more than 90 countries. Joining Peters Surgical means becoming part of a dynamic organization and contributing to the growth of an expanding company. In this context, we are looking for a:  

Validation Engineer (M/F) – Permanent Contract

Domalain – 35 (near Vitré and Rennes)

  Reporting to the Validation Director, you will oversee the validation activities for the French sites to ensure compliance with regulatory requirements, coordinating and planning validation/qualification activities according to the group’s Validation Master Plan (VMP). Your main tasks include:  

• Participate in and/or lead activities related to the validation and maintenance of the validated state of manufacturing processes with support from the industrialization, quality, and R&D departments, according to the project:

- Participate in and follow up on the implementation of the validation master plan. - Manage the validation of sterilization processes for both outsourced and in-house processes, and follow the periodic validation schedule. - Manage the validation of packaging processes and monitor the periodic validation schedule. - Manage the validation of controlled environment zones (ZEC). - Maintain and oversee the monitoring of validated processes: Technical review of the validation status for processes related to sterilization, packaging, cleaning, and ZEC, planning necessary activities to maintain this status. - Manage revalidation activities in accordance with regulatory requirements. - Write and/or review protocols and reports, and lead tests.  

• Participate in the qualification of equipment and validation of processes for new products.

 

• Provide technical support to the group's international validation department.

Other tasks include:

• Participate in activities related to the verification/validation of software used in manufacturing processes.
• Participate in the definition of User Requirement Specifications (URS) for new equipment.
• Participate in FAT/SAT activities for new equipment.
• Participate in FMEA activities.

  The position is based in Domalain (35680) Near Vitré and Rennes.