Staff Process Engineer - Parenterals NPI & Lifecycle

Johnson and Johnson; Schaffhausen; Vor Ort; CHF 100.000 - 140.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Schaffhausen, Switzerland, is seeking a Staff Process Engineer Parenterals New Product Introduction & Life Cycle Management to introduce new products into commercial production and implement new technologies in line with transfer plans.

You will support parenterals inspections, regulatory filings, and health authority responses as the subject matter expert for production topics, focusing on drug product filling processes.

Qualifikationen

• Bachelor's degree in natural sciences or engineering is required; a master's degree is preferred.
• Preferably 4+ years of experience in the pharmaceutical industry, including at least 2 years in parenteral or pharmaceutical manufacturing or development.
• Experience introducing parenteral products into manufacturing sites is preferred.
• Knowledge of late-stage development activities and manufacturing site unit operations (e.g., compounding, milling, filling).
• Strong planning and logistics skills to integrate drug product deliverables at manufacturing level.
• Knowledge of SAP, PAS-X or equivalent systems.
• Excellent written and verbal communication; proficiency in German and English.

Aufgaben

• Act as a core team member in technology transfer projects for the commercialization of new products.
• Prepare and execute engineering runs, clinical batches, and validation batches with Operations, Engineering, and MSAT.
• Lead and support improvement projects that strengthen process robustness, compliance, and operational performance.
• Manage change controls, recipes, and document updates related to assigned projects and processes.
• Train shop floor teams and leadership on project content and process changes.
• Serve as subject matter expert in project-related audits and inspections.
• Collaborate with Production and other partners to ensure aligned implementation.

Kenntnisse

Agile Manufacturing

Data Analysis

Process Optimization

Program Management

Project Administration

Ausbildung

Bachelor's degree in natural sciences or engineering

Master's degree preferred

Tools

SAP

PAS-X

Jobbeschreibung

Johnson & Johnson in Schaffhausen, Switzerland, is seeking a Staff Process Engineer Parenterals New Product Introduction & Life Cycle Management to introduce new products into commercial production and implement new technologies in line with transfer plans.

You will support parenterals inspections, regulatory filings, and health authority responses as the subject matter expert for production topics, focusing on drug product filling processes.