SME Commissioning & Qualification (C&Q) - Sterile & Aseptic
Antwerp
Life Sciences - Validation and Qualification
Bachelor, Master
Work experience: 5-7
Reference number: 93661
Our client, a leading pharmaceutical organization, is seeking an expert to oversee commissioning and qualification activities within their production environment. The role focuses on ensuring that equipment and utilities remain in a state of control while complying with strict regulatory and business specifications.
Your responsibilities:
- Coordinate qualification activities and maintain technical ownership of equipment qualification files.
- Review and approve qualification documentation including URS, DQ, IQ, OQ, and PQ using paperless systems.
- Perform detailed assessments for projects, modifications, and remediations within a GMP environment.
- Manage non-conformances and corrective actions while ensuring compliance with global regulatory guidelines.
- Maintain the Validation Master Plan (VMP) and support internal and external inspections.
- Serve as a coach and technical mentor to junior qualification engineers.
What are we looking for?
- You have a Master’s degree in a technical or scientific field.
- You bring 5+ years of relevant pharmaceutical experience in a GMP-regulated environment.
- You possess deep technical knowledge of aseptic and sterile equipment and manufacturing processes.
- You have extensive experience in Commissioning & Qualification (C&Q) including documentation review and technical writing.
- You're an effective communicator with experience in coaching or mentoring technical team members.
- You are fluent in English.
Nice to Haves
- Knowledge of KNEAT or similar paperless validation systems.
- Active knowledge of Dutch.
What do we 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.
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