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Senior Compliance Engineer – Process Engineering

jj · Schaffhausen

Nouveau
Senior 🇬🇧 English
HVAC systems SAP Product Lifecycle Management Technical writing Vendor selection Process engineering Process control Process improvements Product costing Product improvements Research and Development Validation GMP compliance Change control Root cause analysis

Description du poste

About the role

Johnson & Johnson is seeking a Senior Compliance Engineer to lead engineering and qualification activities for process equipment, utilities, facilities and computerized systems in an aseptic fill‑finish environment. The role supports operation of the Fill & Finish pilot plant and drives technical improvements.

Key responsibilities

  • Provide technical support for process equipment operation and production in the pilot plant.
  • Lead troubleshooting, corrective actions and documentation for technical issues and non‑conformances.
  • Manage technical changes and optimization initiatives through the change‑control process.
  • Oversee the technical work‑order system in collaboration with mechanics and Technical Services.
  • Deliver training and instructions to operators and staff at system and process level.
  • Support evaluation, qualification and implementation of new technology platforms in an aseptic environment.
  • Collaborate with local and global engineering functions on cross‑functional projects.

Required profile

  • 4–6 years of experience in pharmaceutical, food or chemical industry with hands‑on GMP compliance support.
  • Proven experience specifying and designing process equipment for aseptic environments.
  • Strong troubleshooting and root‑cause analysis skills.
  • Fluent in German and English, both written and spoken.
  • Ability to lead project teams and manage budgeting basics.

Required skills

  • HVAC systems knowledge and certification monitoring.
  • SAP Product Lifecycle Management.
  • Technical writing and procedure development.
  • Vendor selection and management.
  • Process engineering, process control and process improvement.
  • Product costing and product improvement analysis.
  • Validation, qualification and change‑control processes.

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Source : ats:workday

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jj

Schaffhausen