Senior C&Q Compliance Engineer - Risk-Based Remediation - Beerse (Employed or freelance)

Functieomschrijving

As a Compliance Engineer, you will join a multidisciplinary project team delivering a Risk Based Remediation project in a GMP-regulated pharmaceutical environment. In this role, you will help review, adapt and execute commissioning & qualification activities using 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 that systems, utilities and equipment are compliant, or are re-qualified, through a pragmatic and risk-driven methodology.

Key responsibilities

• Execute and support Commissioning & Qualification activities (IQ, OQ, PQ) using a risk-based approach
• Review and assess existing qualification documentation as part of remediation activities
• Author, update and execute C&Q documentation, including protocols, reports and traceability matrices
• Perform and document risk analyses, such as FMEA and impact assessments, to support risk-based decisions
• Support internal and external audits and inspections
• Contribute to the continuous improvement of C&Q processes and methodologies
• Communicate project progress, risks and issues clearly to stakeholders

Jouw profiel

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, Chemistry or a related field
• Relevant experience within a GMP-regulated environment, such as pharmaceuticals, biotech or medical devices
• Several years of experience as a C&Q Engineer
• Proven experience with Risk Based C&Q and/or Risk Based Remediation projects
• Experience qualifying equipment, utilities and/or systems
• Strong knowledge of GMP regulations, guidelines and C&Q principles
• Solid risk assessment skills and a pragmatic approach to decision-making
• Experience writing and reviewing technical and quality documentation
• Strong communication skills and the ability to align with multiple stakeholders
• Fluent in English; Dutch is a plus, but not mandatory

💼 Offer

You will be part of a growing Belgian SME where initiative and personal development are encouraged. We will provide you with an enjoyable work environment with fun colleagues. We will work out a career plan with you, with attention and a budget for extra education/certification. You can count on an attractive salary, supplemented with extra-legal benefits, including a company car.
(Freelance is also possible)