Staff Process Engineer Parenterals NPI/LCM

vor 2 Wochen


Schaffhausen, Schaffhausen, Schweiz Johnson & Johnson Innovative Medicine Vollzeit

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function
Supply Chain Manufacturing

Job Sub Function
Manufacturing Pharmaceutical Process Operations

Job Category
Professional

All Job Posting Locations:
Schaffhausen, Switzerland

Job Description
Johnson&Johnson's Innovative Medicine is recruiting for a
Staff Process Engineer
in the Parenterals Manufacturing and Filling Operations organization, located in
Schaffhausen, Switzerland.
At the Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.

As a Staff Process Engineer Parenterals New Product Introduction & Life Cycle Management you are responsible for the introduction of new products in our commercial production and implementation of new technologies and processes in alignment with tech transfer plans and business objectives. You will support innovation, cost improvement and compliance projects in parenterals operations and assure robust and reliable process implementation in close collaboration with the operations units. Your responsibilities include support of inspections, filings and health authority responses acting as subject matter expert for production related topics.

This role will focus on drug product compounding processes.

Job Responsibilities

  • Execution and support of projects in New Product Introduction and Lifecycle Management in the Business Unit Parenterals.
  • Execution and support of improvement projects.
  • Responsible for change controls, recipe and document changes.
  • Handling of quality investigations concerning process and material deviations.
  • Training of project related content on the shop floor and in the leadership teams.
  • Acts as Subject Matter Expert in project related audits
  • Close collaboration with production as well as with other relevant business partners.
  • Follows GMP, EHS and SOX guidelines.

Qualifications

  • A minimum of a bachelor's degree in natural science or engineering is required. Master's degree preferred
  • Preferred 4+ years of experience in various fields in Pharmaceutical industry with a minimum of 2 years in a role involved in parenteral/pharmaceutical manufacturing or development
  • Preferably experience with introduction of parenteral products into manufacturing sites (biotechnologically produced and/or chemically synthesized APIs), late-stage development activities as well as technical and process knowledge of manufacturing site unit operations (e.g. compounding, milling, and filling of liquid formulations and suspensions)
  • Strong planning and logistics skills to effectively integrate drug product deliverables and execution at the manufacturing level
  • Knowledge of manufacturing site systems and procedures (e.g. SAP, PAS-X or equivalent)
  • Excellent written and oral communication skills and ability to influence partners, peers and collaborators at all levels
  • Proficiency in German and English is a requirement
  • Ability to work independently with proven problem-solving skills

Why Join Us?
Become part of a forward-thinking company committed to excellence in pharmaceutical manufacturing. In this role, you will have the opportunity to work in a collaborative environment, contribute to meaningful projects, and make a lasting impact on our best in class innovative processes. We look forward to welcoming you to our team

Required Skills
Good Manufacturing Practices (GMP), Stakeholder Collaboration, Sterile Compounding



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