Project Engineer Validation & Qualification

Our client, a leading pharmaceutical organization, is seeking a senior professional to lead validation and planning efforts for major capital projects. This role focuses on ensuring rigorous compliance with international quality standards while managing project lifecycles, product introductions, and technical coordination between departments.

• Lead the coordination of verification and validation activities for large-scale engineering and capital projects.
• Interpret and apply international regulations including GMP, ISO, and ICH to ensure project compliance.
• Draft, review, and approve critical validation documentation and technical project plans.
• Serve as the primary point of contact for Engineering and Quality Assurance regarding validation and change control.
• Facilitate comprehensive Quality Risk Assessments and provide subject matter expertise in QRM.
• Oversee the qualification of laboratory method improvements and the development of computer-controlled systems.
• Manage complex projects, addressing urgent quality investigations and implementing strategic risk assessments.

• You possess a Master’s degree in Civil Engineering, Industrial Engineering, Bio-engineering, Pharmacy, or a related scientific discipline.
• You have 8+ years of experience in project engineering and validation within a pharmaceutical production environment.
• You bring advanced knowledge of GMP regulations, ISO standards, and Quality Risk Management (QRM).
• You have technical expertise in aseptic processes, cleaning, disinfection, and sterilization.
• You possess strong stakeholder management, organizational skills, and professional technical writing abilities.
• You are fluent in Dutch and English.

Nice to Haves

• Experience in team management and the coordination of cross-functional technical resources.
• Proven track record of executing strategic initiatives and developing innovative technical solutions.

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
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• Grijp kansen op elk niveau, van een sterke start tot doorgroeimogelijkheden en samenwerking met experts.