Staff Parenteral NPI & Life‑Cycle Process Engineer

Johnson & Johnson Innovative Medicine; Schaffhausen; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

Johnson & Johnson Innovative Medicine in Schaffhausen seeks a Staff Process Engineer Parenterals New Product Introduction & Life Cycle Management to lead the transfer of new products into commercial parenteral production and to implement new technologies in line with technology transfer plans.

You will support process improvements, regulatory filings, and inspections as the subject matter expert, collaborating with Operations, Engineering, and MSAT to ensure robust, compliant production.

Qualifikationen

• Bachelor’s degree in natural sciences or engineering required; master preferred.
• 4+ years in pharmaceutical industry, with 2+ years in parenteral manufacturing or development.
• Experience introducing parenteral products into manufacturing sites.
• Knowledge of late-stage development and manufacturing unit operations (filling, compounding, milling).

Aufgaben

• Act as core team member in technology transfer projects.
• Prepare and execute engineering runs, clinical batches, and validation batches.
• Lead improvement projects to enhance robustness and compliance.
• Manage change controls, recipes, and document updates.
• Train shop floor and leadership on project content and process changes.
• Serve as SME in audits and inspections.
• Collaborate with Production and other partners for aligned implementation.
• Follow GMP, EHS, and SOX guidelines.

Kenntnisse

Agile Manufacturing

CMC

Communication

Cost-Benefit Analysis

Critical Thinking

Data Analysis

Gap Analysis

GMP

Industry Analysis

Mentorship

Operational Excellence

Pharmaceutical Industry

Plant Operations

Problem Solving

Process Optimization

Program Management

Project Administration

Ausbildung

Bachelor's degree in natural sciences or engineering

Master's degree preferred

Tools

SAP

PAS-X

Equivalent systems

Jobbeschreibung

Johnson & Johnson Innovative Medicine in Schaffhausen seeks a Staff Process Engineer Parenterals New Product Introduction & Life Cycle Management to lead the transfer of new products into commercial parenteral production and to implement new technologies in line with technology transfer plans.

You will support process improvements, regulatory filings, and inspections as the subject matter expert, collaborating with Operations, Engineering, and MSAT to ensure robust, compliant production.