Job Openings CVQ Engineer

About the job CVQ Engineer


Location: Woodlands Close

Job Scope/Requirements:
Responsibilities
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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