NOVA Engineering zoekt een GMP Validation Engineer in Geleen
Productie en Onderhoud
Wat ga je doen? technische job 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.
Wat verwachten wij van jou? technische job GMP Validation Engineer
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
Waar ga je werken?
NOVA Engineering is an agency focused on projectsourcing of engineers and high technical profiles. We are the match between companies with a specific need of technical expertise and specialized engineers.
Wat kun je van ons verwachten? technische job GMP Validation Engineer
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