SME Commissioning & Qualification (C&Q) - Sterile & Aseptic

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.

• 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.

• 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.

• 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.