About this role
As a compliance engineer, you will be part of a multidisciplinary project team responsible for the execution of a Risk Based Remediation project within a GMP-regulated pharmaceutical environment. You will actively contribute to reviewing, adapting, and executing commissioning & qualification activities based on 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 systems, utilities, and equipment are compliant or re-qualified using a pragmatic, 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 (protocols, reports, traceability matrices) Perform and document risk analyses (e.g. FMEA, impact assessments) to support risk-based decisions Support internal and external audits and inspections Contribute actively to continuous improvement of C&Q processes and methodologies Communicate project progress, risks, and issues to stakeholders Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related field Relevant experience within a GMP-regulated environment (pharmaceutical, 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 and pragmatic decisionm-aking skills Experienced in writing and reviewing technical and quality documentation Strong communication skills and ability to align with multiple stakeholders Fluent in English (Dutch is a plus, but not mandatory)