- Singapore
Working Location
Job Description
Responsibilities
We are partnering with a global MNC headquartered in the US who is renowned for their CDMO / CRO services and full suite of solutions in supporting laboratory testing and manufacturing activities. As a key provider of microbiological services, they are now looking to expand the Validations & Facilities team in Singapore. This is an important headcount with a clear pathway to take on a Team Lead role as the team grows.
Responsibilities
Reporting to the Senior Facilities Manager, this role is responsible for leading end-to-end validation activities across equipment, facilities, utilities, and systems within a regulated laboratory environment. This includes planning and executing validation projects (including IQ/OQ/PQ), developing and maintaining validation protocols and SOPs in compliance with cGMP, ISO 17025, GAMP 5, and USP 1058 standards, and leading vendor evaluations for capital equipment submissions. You will also lead and participate in validation project meetings, produce documentation in line with good documentation practices, and represent the department as a subject matter expert during client audits and regulatory inspections.
The role additionally involves leading root cause analysis for investigations using structured tools such as the Ishikawa fishbone diagram, managing project timelines and cross-functional stakeholder communications, driving continuous improvement initiatives, and monitoring cost expenditure for the department.
Requirements
The ideal candidate is someone with at least 5 years of hands-on experience in Equipment and Validation projects, ideally within the Pharmaceutical, Medical Devices, and/or Biotechnology manufacturing or contract lab environment. You will need to be familiar working in an ISO 17025 / GMP regulated environment, with solid understanding of system commissioning, qualification and validation as per GAMP 5 and USP 1058. Candidates with some experience in mentoring or supervising junior engineers will be well-positioned for the Team Lead progression.
If you would like to be considered for this opportunity, please apply to the advertisement or forward a copy of your full CV to *************.
Business Registration Number: 202509847W | Licence Number: 25S2778 | EA Registration Number: R1653095
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