Beschreibung
Job Title: CQV EngineerLocation: Switzerland
Duration: 12 months
Main responsibilities
As part of the CQV Team reporting to the CQ Manager main responsibilities and tasks of the incumbent includes but are not limited to:
- Attendance at Factory Acceptance Tests for key process equipment to witness and validate.
- Compliance with URS, DQ and FAT protocols.
- Assess vendor compliance with applicable codes and standards.
- Raise punch items and sign off on FAT report.
- Execution of Walk Down of mechanically complete (MC) systems including.
- Execution of Installation Verification (IQ) including
- Execution of Operational Verification (OQ) including:
- Compliance with scheduling including
- Safety Compliance including
Key Performance Indicators
Strong knowledge and experience of Commissioning and
- Management: Compliance with schedule at a system and area level with the planned resource
- Feedback from customer (i.e. Quality, HSE, operations)
- Safety: No lost time accident
- Quality: Well executed testing with minimum rework and re-execution.
- Quality: All deviations resolved to Client satisfaction and handover completed for all systems.
Qualification & Experience Requirements
Education (minimum/desirable): Minimum BS or equivalent in Engineering or Science -preferably in Automation, Chemical, Mechanical or Pharmaceutical
- Experience in Commissioning and Qualification of Clean Utilities and
- Experience in Commissioning and Qualification for the following equipment (HVAC, Buffer prep and hold, Single Use Mixers, Tangential Flow Filtration, Chromatography, COTS (freezers, fridges, probes (pH and UV))
- Languages:
- English - Essential fluent in speaking and
- German - Essential fluent in speaking and writing essential
- Broad knowledge of engineering disciplines, commissioning, compliance, qualification and validation.
- Excellent knowledge of Validation processes (IQ/OQ/PQ) and current regulatory requirements related to E2500 and ISPE
- Experience working within a GMP manufacturing environment
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.