Process Engineer – New Product Introduction & Life Cycle Management
jj · Schaffhausen
Description du poste
About the role
As a Staff Process Engineer for Parenterals New Product Introduction & Life Cycle Management, you will lead the introduction of new products into commercial production and implement new technologies in line with technology transfer plans and business objectives.
Key responsibilities
- Act as a core team member in technology transfer projects for commercializing new products.
- Prepare and execute engineering, clinical, and validation batches in collaboration with Operations, Engineering, and MSAT.
- Lead improvement projects to strengthen process robustness, compliance, and operational performance.
- Manage change controls, recipes, and document updates for assigned projects.
- Train shop‑floor and leadership teams on project content and process changes.
- Serve as subject‑matter expert during audits and inspections.
Required profile
- Bachelor’s degree in natural sciences or engineering (master’s preferred).
- 4+ years of pharmaceutical experience, including at least 2 years in parenteral manufacturing or development.
- Experience introducing parenteral products into manufacturing sites.
- Strong planning and logistics skills for drug product deliverables.
- Proficiency in German and English.
Required skills
- Good Manufacturing Practices (GMP) knowledge.
- Experience with SAP or equivalent manufacturing execution systems.
- Familiarity with PAS‑X or similar batch management systems.
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jj
Schaffhausen