Process Engineer – Parenteral NPI & Life Cycle Management

About the role

Johnson & Johnson seeks a Staff Process Engineer to lead new product introductions and life‑cycle management for parenteral drug products. You will work closely with operations, engineering, and manufacturing science teams to ensure robust, compliant processes from lab to commercial production.

Key responsibilities

• Act as core team member in technology transfer projects for commercializing new parenteral products.
• Prepare and execute engineering, clinical, and validation batches in collaboration with Operations, Engineering, and MSAT.
• Lead improvement projects to enhance process robustness, compliance, and operational performance.
• Manage change controls, recipes, and related documentation 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 into manufacturing sites, including biotech or chemically synthesized APIs.
• Strong planning and logistics skills for drug‑product deliverables.
• Proficiency in German and English.

Required skills

• Knowledge of GMP, EHS, and SOX guidelines.
• Familiarity with manufacturing site systems such as SAP and PAS‑X.
• Experience with compounding, milling, and filling of liquid formulations and suspensions.
• Change control and documentation management.