GMP Validation Engineer

Our partner is a pharmaceutical multinational specialized in cell and gene therapy manufacturing with a high-tech site in Geleen. For this site, we are looking for a Validation Engineer to ensure all critical GMP regarding equipment, facility and/or systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines.

• Draft the necessary validation documentation such as IOQ and PQ protocols for the validation of GMP equipment, facility and/or systems within client Netherlands site.
• Execute validation and re-qualification activities, including CSV activities when applicable, to ensure GMP equipment, facility and/or system is continuously maintained in a validated state. Reporting on executed validation activities according GDP and getting the reports approved in the Quality System.
• Schedule own tasks to be performed according the prioritization aligned with the Validation Team Lead.
• Perform change control assessments for GMP equipment, facility and/or system and associated validation activities to ensure compliance with regulatory requirements.
• Demonstrate a thorough understanding of Cell and Gene manufacturing equipment, facility and/or system and validation procedures for Installation Qualification (IQ), Autoclaves, Clean Utilities, Temperature Mapping Controlled Storage Rooms and Equipment.
• Develop validation protocols from Validation plans (where/as applicable).
• Provide strong technical expertise when reviewing and approving SOPs, protocols, change controls, deviations.
• Perform assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc). Perform other duties as assigned.

• Preferably 1 – 5 years experience
• First experience in GMP (ideally in validation/qualification), with interest in CSV is a nice to have
• Scientific background / education at least Bachelor level
• Fluent in English
• Prepared to work at least 3 days/week onsite and maximum 2 days/week remote

• Our short lines of communication and flat organisational structure form the base for personal guidance and coaching in your career path at NOVA Engineering
• The diversity of projects will further develop your expertise in your field, both in width and depth.
• A boost in expanding your professional network through challenging projects
• We provide a contract with indefinite duration, an attractive salary with company car and various extra legal benefits
• As freelancer, you can count on little administration, personalized coaching and payment of your invoice within 2 weeks