Are you a hands-on Commissioning & Qualification expert with strong GMP experience and a passion for ensuring sterile manufacturing equipment performs at the highest standards?
For an Innovative Medicine Supply Chain site in Beerse, we are looking for a Commissioning & Qualification (C&Q) Lead / Subject Matter Expert to support qualification activities and act as a Technical Owner within the organization.
Key Responsibilities
* Act as Technical Owner for equipment and utilities within the Beerse site
* Support the C&Q team in delivering documented evidence of qualification compliance
* Coordinate qualification activities and manage the technical content of Equipment Qualification files
* Perform technical assessments for projects, modifications, and remediation activities
* Review and approve qualification documentation in KNEAT (paperless validation), including:
* URS, SRS, SIA, DQ, IQ, OQ, PQ
* Initiate and follow up on deviations and corrections in COMET
* Coach qualification engineers and provide technical guidance
* Maintain Validation Master Plans and ensure full GMP compliance
What We're Looking For
* Minimum 5 years of experience in pharma or biotech within a GMP environment
* Strong technical knowledge of aseptic / sterile equipment and processes
* Solid understanding of qualification lifecycle documentation (URS through PQ)
* Experience with KNEAT and COMET is highly preferred
* Able to manage multiple qualification assessments simultaneously
* Strong communication and coaching skills
* Fluent in English (Dutch is a strong advantage)
What can you expect?
* Company car and net expense allowance: You will receive an attractive salary package, including a company car.
* Training and development opportunities: Arcadis offers a wide range of internal and external training programs to expand your expertise and further develop your career.
* International network: Become part of a global network of professionals and collaborate with colleagues and clients around the world.
* Innovation and sustainability: Contribute to innovative and sustainable projects that truly make a difference.
Choosing Arcadis means working in a dynamic environment on exciting projects, with excellent opportunities for personal and professional growth!
Join Arcadis. Create a Legacy