Senior Compliance Engineer – Process Engineering
jj · Schaffhausen
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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jj
Schaffhausen