Project Engineer - CAPEX (m/f/d)
Freelance/temporary employment for a project Visp Start date: asap Reference number: 877914/1
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Responsibilities
1. Define technical requirements and success criteria aligned with GMP standards and operational objectives
2. Develop and manage the full project roadmap from concept design through performance qualification (PQ)
3. Act as the main technical point of contact for all mechanical adaptations and process improvements
4. Ensure compliance with GMP regulations and internal quality standards
5. Manage and coordinate change control processes in collaboration with QA
6. Align and coordinate cross-functional teams across operations, engineering, maintenance, and quality
7. Monitor project progress, timelines, budgets, and key milestones
8. Conduct risk assessments and implement mitigation strategies
9. Lead commissioning and qualification activities including IQ, OQ, and PQ
10. Collaborate with validation teams to ensure effectiveness and compliance of implemented changes
Profile
11. Bachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or related field
12. Solid experience in biopharmaceutical manufacturing or GMP-regulated environments
13. Proven track record in technical project management or operational excellence initiatives
14. Strong experience with GMP processes, change management, and CQV activities
15. Solid understanding of commissioning, qualification, and validation methodologies
16. Strong project management and organizational skills with the ability to manage multiple workstreams
17. Excellent problem-solving skills in complex and fast-paced environments
18. Strong communication and stakeholder management capabilities
19. Fluent German preferred and strong English skills required
Benefits
20. Opportunity to work on high-impact projects in a GMP-regulated biopharma environment
21. Exposure to complex, cross-functional projects with strategic relevance
22. Professional development and continuous learning opportunities
23. Collaborative and international work environment