- Clean Utilities:
- WFI Generation Systems
- WFI Storage Tanks
- WFI Distribution
- Clean Steam Generators
- Clean Steam Distribution
- O2/ CO2/ N2 Distribution
- Compressed Air (Oil Free) Distribution
- Strong knowledge and experience of Facilities and Utilities Commissioning and Qualification in a Biotech or Biologics Manufacturing environment.
- Management: Compliance with schedule at a system and area level with the planned resource levels.
- Feedback from customer (i.e. Quality, HSE, operations)
- Safety: No lost time accident
- Quality: well executed testing with minimum rework and re-execution.
- Education (minimum/desirable): Minimum BS in Engineering or Facility Management - preferably in Chemical, Mechanical, Facility, Industrial, Quality or Pharmaceutical Engineering.
- SME Clean Utility systems.
- Has lead teams, managed schedule and reported to management on team performance.
- Languages: English - fluent in speaking and writing.
- Experience: Minimum 8 yrs. plus of Biotech or Pharmaceutical cGMP experience is required.
- Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.
- Has successfully defended systems before FDA, EMA etc. inspections.
- CQV documentation experience Using KNEAT Software an advantage
- Experience in using Delta V, PI Historian and PLC Systems essential
- Excellent technical writing skills. Expert GMP/QA knowledge.
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Clean Utilities Lead - Bern, Schweiz - Project Delivery Partners
Beschreibung
Job Summary
The successful candidate will manage the Clean Utility CQV team, including all deliverables for the new facilities and utilities scope.
The function will be to plan, supervise and manage all works associated with all Clean Utility CQV documentation, walkdown, commissioning and qualification of the following systems:
Main responsibilities
Exclusions
Document preparation being completed by others.
Key Performance Indicators
Ideal Background