CQV Engineer
8 hours ago
ALL JOBS LISTED ARE BASED IN SINGAPORE ONLY. FOR SINGAPOREAN ONLY.
Job description:
• Lead Commissioning, Qualification & Validation (CQV) activities
• Lead a team and execute all field work such as Commissioning, Installation & Operational Qualification (IQ/OQ), Validation for downstream process equipment, CIP & Clean utilities to complete assigned tasks on time, on budget and safely while adhering to quality and engineering standards.
• Write and review project design documents (P&IDs, PFDs, URS, data sheets etc.), GMP/GDP documents and technical specifications, protocols preparation, execution and follow-up.
• Review and follow-up the technical documentation from the early design phase in order to align it with GMP and C&Q requirements
• Preparation and review of FAT, Commissioning and SAT protocols.
• Support the preparation of the final reports to the end-user
• Perform risk analysis and review performance progress.
• Support the preparation of the final reports to the end-user
• Coordinate with vendor & contractors to achieve streamlined CQV.
• To perform other related duties as assigned by management
Requirements:
• Degree in Engineering/Science related discipline.
• Minimum 5 years' relevant experience in commissioning and qualification activities for construction projects in pharmaceutical facilities.
• Thorough knowledge of pharmaceutical guidelines e.g. GMP, GDP, ASTM E2500-07, FDA, ICH, ISPE and CQV practices.
• Candidates with senior experiences will be considered for a senior role.
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