Functieomschrijving
As a compliance engineer, you will be part of a multidisciplinary project team responsible for the execution of a Risk Based Remediation project within a GMP?regulated pharmaceutical environment. You will actively contribute to reviewing, adapting, and executing commissioning & qualification activities based on a risk?based approach, in line with applicable regulations and quality standards.
You will work closely with Engineering, Quality Assurance, Operations, and external partners to ensure systems, utilities, and equipment are compliant or re?qualified using a pragmatic, risk?driven methodology.
Key Responsibilities:
1. Execute and support Commissioning & Qualification activities (IQ, OQ, PQ) using a Risk Based approach
2. Review and assess existing qualification documentation as part of remediation activities
3. Author, update, and execute C&Q documentation (protocols, reports, traceability matrices)
4. Perform and document risk analyses (e.g. FMEA, impact assessments) to support risk?based decisions
5. Support internal and external audits and inspections
6. Contribute actively to continuous improvement of C&Q processes and methodologies
7. Communicate project progress, risks, and issues to stakeholders
Profiel
Education & Background
8. Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related field
9. Relevant experience within a GMP?regulated environment (pharmaceutical, biotech, or medical devices)
Experience
10. Several years of experience as a C&Q Engineer
11. Proven experience with Risk Based C&Q and/or Risk Based Remediation projects
12. Experience qualifying equipment, utilities, and/or systems
Knowledge & Skills
13. Strong knowledge of GMP regulations, guidelines, and C&Q principles
14. Solid risk assessment and pragmatic decision?making skills
15. Experienced in writing and reviewing technical and quality documentation
16. Strong communication skills and ability to align with multiple stakeholders
Languages
17. Fluent in English (Dutch is a plus, but not mandatory)
Organisatie- en afdelingomschrijvingAt Select Projects, the experience our clients have with our consultants is central. It is our consultants who ensure an outstanding experience by delivering the highest level of quality. Your craftsmanship is key in this, and at Select Projects you are given the opportunity to continue growing, so that you can become — and deliver — the best version of yourself. As a consultant, you bring knowledge and expertise, combined with the drive to succeed. And what do you get in return?
Select Projects offers content-driven and engaging projects, clear growth opportunities, autonomy, trust, training, and skilled colleagues from whom you can learn. This allows you to fully focus on your professional growth and personal development.
For a Risk Based Remediation project, we are currently looking for experienced compliance profiles.AanbodSelect Projects ensures that you will work in a pleasant and stimulating working environment with great colleagues, where team spirit is key. We regularly organize after-work events, company parties, sports activities, and team-building events.
We offer you ample opportunities to grow and further develop yourself. Together with you, we create a personalized training and development plan tailored to your future ambitions and needs. At Select Projects, you are enabled to become — and give — the very best version of yourself.
In addition, Select Projects offers you a permanent contract.
You will receive an attractive salary package, including the following fringe benefits:
18. Company car (electric) with fuel card
19. Meal vouchers & eco vouchers
20. Expense allowance
21. Group and hospitalization insurance
22. 12 ADV days per year
23. End-of-year bonus
24. Single and double holiday pay
25. Bonus system: collective bonus and individual bonus
26. Possibility to participate in a Flex Income Plan