Commissioning & Qualification Lead
Location: Beerse, Belgium
Duration: 12 months contract assignment
Hours: 40 hrs (4 days onsite, 1 day home office)
Essential: 5 years of pharmaceutical or biotech experience (GMP environment), technical knowledge of aseptic/sterile equipment/processes required, English & Dutch conversational
Imagine your next project ensuring that life-saving pharmaceutical equipment operates at the highest standards of safety and precision.
As a Commissioning & Qualification (C&Q) Subject Matter Expert, you will be the technical heartbeat of the Innovative Medicine Supply Chain in Beerse. You will ensure that all equipment and utilities remain in a state of control, delivering products that comply with strict regulatory and business specifications.
roles and responsibilities.
You will act as a Technical Owner within the IM SC Beerse organization.
This will involve:
* Supporting the C&Q group in providing documented evidence that all equipment and utilities are qualified.
* Coordinating qualification activities and managing the technical content of Equipment Qualification files.
* Making detailed assessments for projects, modifications, and remediations assigned by the C&Q lead.
* Reviewing and approving qualification documents (URS, SRS, SIA, DQ, IQ, OQ, PQ) in the KNEAT paperless system.
* Initiating and following up on non-conformances and corrections in COMET.
* Serving as a coach to qualification engineers and providing technical guidance.
* Maintaining area Validation Master Plans and ensuring compliance with GMP requirements.
how to succeed.
You are a detail-oriented technical expert with a deep understanding of international regulations and industry practices in process equipment qualification.
You will also bring:
* Proven experience in Commissioning & Qualification within a GMP environment.
* Strong knowledge of qualification documentation (URS, DQ, IQ, OQ, PQ).
* Experience with KNEAT (paperless validation) and COMET is highly preferred.
* Ability to act as a Technical Owner and manage multiple project assessments simultaneously.
* Excellent coaching skills to guide qualification engineers and technical writers.
* Fluency in English (Dutch is a significant advantage for the Beerse site).
benefits.
This role offers a very competitive hourly rate. This contract will run for 12 months
you are welcome here.
Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
about Innovative Medicine
Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and work to help people live longer, healthier lives.
application process.
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email.
Diversity, Equity & Inclusion.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.