Life Sciences Validation & Compliance Project Engineer
Capgemini
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Benefits offered by this job
Job summary
Capgemini Engineering is seeking a Medior Project Engineer for Validation & Compliance to coordinate validation activities in regulated pharma projects. You will liaise between Engineering and Quality Assurance, draft protocols, monitor schedules, and ensure GMP-aligned documentation throughout project lifecycles.
Your profile includes a Master's in engineering or related science, 2+ years in a regulated environment, and fluent Dutch and English with strong technical writing.
Qualifications
- Master's degree in engineering or related field is required.
- Minimum 2 years of experience in a regulated pharmaceutical or production environment with GMP.
- Fluent in Dutch and English with strong technical writing capabilities.
- Experience with aseptic processes, cleaning or sterilisation is a plus.
Responsibilities
- Coordinate validation and verification activities across capital projects, developing and monitoring schedules.
- Interpret and apply GMP regulations (US and EU), ISO and ICH standards, ensuring compliance.
- Draft, review, and manage validation protocols and qualification documents with rigorous documentation.
- Facilitate Quality Risk Assessments (QRM) and support investigations, deviations and change control.
- Manage one or more projects, contribute to continuous improvement, and support new product introductions.
- Assist qualification and validation of analytical methods and provide backup support to teammates.
Skills
Education
Job description
Capgemini Engineering is seeking a Medior Project Engineer for Validation & Compliance to coordinate validation activities in regulated pharma projects. You will liaise between Engineering and Quality Assurance, draft protocols, monitor schedules, and ensure GMP-aligned documentation throughout project lifecycles.
Your profile includes a Master's in engineering or related science, 2+ years in a regulated environment, and fluent Dutch and English with strong technical writing.
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