Parenterals Process Engineer – NPI & Lifecycle

jj

Schaffhausen

On-site

CHF 120,000 - 150,000

Full time

6 days ago
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Job summary

Johnson & Johnson is seeking a Staff Process Engineer for Parenterals New Product Introduction & Life Cycle Management in Schaffhausen. You will introduce new products into commercial production and drive technology transfer, process improvements, and compliance programs across parenterals operations.

You will support inspections, regulatory filings, and health authority responses as the subject matter expert, ensuring robust, reliable process implementation in collaboration with operations

Qualifications

  • Bachelor’s degree in natural sciences or engineering is required; a master’s degree is preferred.
  • 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, including products with biotechnologically produced and/or chemically synthesized APIs.
  • Knowledge of late-stage development activities and manufacturing site unit operations, such as compounding, milling, and filling of liquid formulations and suspensions.
  • Strong planning and logistics skills to integrate drug product deliverables and execution at the manufacturing level.
  • Knowledge of manufacturing site systems and procedures, such as SAP, PAS-X, or equivalent systems.
  • Excellent written and verbal communication skills, with the ability to influence partners, peers, and collaborators at all levels.
  • Proficiency in German and English is required.

Responsibilities

  • 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 in close collaboration 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 teams on project-related content and process changes.
  • Serve as subject matter expert in project-related audits and inspections.
  • Collaborate closely with Production and other relevant business partners to ensure aligned implementation.
  • Follow applicable GMP, EHS, and SOX guidelines.

Skills

German language proficiency
English language proficiency
Problem solving
Project management
Agile manufacturing
Data analytics
Process optimization

Education

Bachelor’s degree in natural sciences or engineering
Master’s degree preferred

Job description

Johnson & Johnson is seeking a Staff Process Engineer for Parenterals New Product Introduction & Life Cycle Management in Schaffhausen. You will introduce new products into commercial production and drive technology transfer, process improvements, and compliance programs across parenterals operations.

You will support inspections, regulatory filings, and health authority responses as the subject matter expert, ensuring robust, reliable process implementation in collaboration with operations

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