Process Engineer – New Product Introduction & Life Cycle Management
jj · Schaffhausen
Description du poste
About the role
Johnson & Johnson is seeking a Staff Process Engineer to lead the introduction of new parenteral products into commercial production and manage life‑cycle activities. The role supports innovation, cost improvement and regulatory compliance within the manufacturing site.
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, inspections and regulatory filings.
Required profile
- Bachelor’s degree in natural sciences or engineering (Master’s preferred).
- 4+ years of pharmaceutical experience, with at least 2 years in parenteral manufacturing or development.
- Experience introducing parenteral products, including biotechnologically produced or chemically synthesized APIs.
- Strong planning and logistics skills for drug‑product delivery at manufacturing level.
- 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 control systems.
- Technical expertise in liquid formulation filling, compounding and milling processes.
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jj
Schaffhausen