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.
About Staffhub Group Pte Ltd
Staffhub Group provides employment placements in Singapore and Asia.
