Validation Engineer
- Location
- Geel, Antwerp
- Work type
- Consultancy
- Work model
- Fulltime, Hybrid
Validation Engineer
Description
The Validation Engineer is responsible for the development, implementation and execution of validation activities for cGMP-critical process systems, ensuring compliance with regulatory, user and internal requirements.
This role involves hands-on validation work and the preparation and execution of validation documentation within a regulated pharmaceutical environment.
Responsibilities
- Develop, implement and execute URS, SIA, DQ, IQ, OQ, PQ, RV and TM validation activities.
- Perform validation studies for cGMP-critical process systems, ensuring compliance with cGMP, user requirements and regulatory standards.
- Conduct system validation where industry standards require interpretation and adaptation to specific cases.
- Ensure the validated status of process systems remains compliant with cGMP requirements at all times.
- Support projects in alignment with Sanofi procedures and regulatory GMP standards.
- Stay up to date with emerging validation regulations and industry best practices.
- Provide technical guidance regarding US FDA and EU validation requirements.
- Generate validation documentation (protocols and reports) and support protocol execution using the Kneat paperless validation system.
- Take responsibility for validation documentation through approval and implementation.
- Assess and review change requests to determine potential impact on validated systems and validation documentation.
Requirements
- Strong knowledge of cGMP requirements in regulated pharmaceutical environments
- Understanding of quality and compliance regulations
- Hands-on experience with Autoclave validation
- Ability to troubleshoot validation issues
Experience
- 2–4 years of experience within the pharmaceutical sector and GMP environment
Nice to Have
- Experience with validation of Clean Steam Generator systems
- Experience with Parts Washer validation
Languages
- English – good knowledge required
- Dutch – good knowledge required
Offer
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
Thank you for your interest. Unfortunately, job applications are not available in your region. To ensure a high-quality match for our clients and streamline the application process, we have certain regional limitations in place. We value all potential candidates and encourage you to explore opportunities with us in the future.
)