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For our client, we are seeking an experienced Technical Project Manager to support CAPEX and optimization projects within a highly regulated GMP environment. In this role, you will lead cross-functional project teams, coordinate with internal and external stakeholders, and ensure timely and compliant delivery of all project activities.
This position plays a key part in driving Annex 1–related improvements across sterile manufacturing operations.
Start Date: ASAP
Contract: Until December 2026 (extension possible)
Workload: Full-time
Your Responsibilities
- Lead, plan, and coordinate all project-related activities across multiple functional areas.
- Act as the primary point of contact for internal stakeholders and external partners.
- Ensure all project deliverables are developed, reviewed, approved, and executed according to schedule, budget, and quality expectations.
- Drive compliant project execution in GMP-regulated and capacity‑constrained environments.
- Support and execute CAPEX and optimization initiatives, including but not limited to:
- Improving sterile filtration processes (e.g., Point of Fill Filtration).
- Developing and implementing an electronic documentation system for Grade A interventions.
- Sealing and infrastructure optimization in Grade D areas.
- Optimizing transitional spaces (MAL) to meet Annex 1 requirements.
Your Profiles
- Bachelor’s or Master’s degree in Mechanical, Electrical, Process, Chemical Engineering, or equivalent.
- Minimum 5 years of experience in technical project execution within GMP‑regulated environments (pharma, biotech, life sciences).
- Hands-on experience with FMEA, technical troubleshooting, and cross-functional project coordination.
- Fluent English and German (spoken and written).
Solid understanding of:
- cGMP
- EU Annex 1
- Engineering documentation
- Strong ability to interpret and apply regulatory expectations in daily project work.
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