Project Engineer Validation (Data integrity)

Our client, a leading pharmaceutical organization, is seeking a Data Integrity Project Engineer to support specialized compliance projects. This role focuses on upgrading production equipment to meet GMP standards and conducting Alcoa Assessments on various systems. The position requires a hands-on approach to validation and cross-departmental coordination within a production environment.

• Coordinate and execute validation activities for equipment upgrades to ensure GMP compliance.
• Perform Alcoa Assessments on production equipment and systems to evaluate data integrity standards.
• Develop and review technical documentation including URS, FAT, SAT, and change control records.
• Conduct Quality Risk Assessments and facilitate risk mitigation strategies within manufacturing areas.
• Collaborate with cross-functional teams to align project deliverables with internal quality standards.
• Monitor system parameters such as user access and audit trails to ensure regulatory compliance.

• Master’s degree in Bio-engineering, Industrial Pharmacy, Biochemistry, Biotechnology, or a related scientific field.
• You have 2+ years of professional experience in project engineering within a pharmaceutical production environment.
• You bring a strong Data Integrity mindset and knowledge of GMP regulations and quality standards.
• You possess experience in validation and qualification processes, including IQ, OQ, PQ, and change control.
• You're proactive, inquisitive, and have excellent communication and stakeholder management skills.
• You are fluent in Dutch and English.

Nice to Haves

• Previous experience with Alcoa principles or data integrity projects at a similar organization.
• Background in aseptic processes, cleaning, disinfection, or sterilization.

• 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.