Clean Utilities Lead

vor 3 Wochen

Bern, Schweiz Project Delivery Partners Vollzeit

Clean Utilities Lead

**Job Description**:
**Job Summary**

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:

- 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

**Main responsibilities**

**Exclusions**

Document preparation being completed by others.

**Key Performance Indicators**
- 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.

**Ideal Background**
- 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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