About the Role
Job Description
The Validation Engineer (SME) leads the Qualification of Equipment, Facilities, and Utilities (E/F/U) systems for major projects in Singapore. In this role, you act as the primary technical authority for Commissioning and Qualification (C&Q), ensuring that all infrastructure meets the rigorous standards required for pharmaceutical manufacturing. You take ownership of the validation lifecycle from initial protocol generation through to final execution, navigating both Greenfield and Brownfield environments to ensure facility readiness and regulatory compliance.
Key Responsibilities
The Validation Engineer (SME) leads the Qualification of Equipment, Facilities, and Utilities (E/F/U) systems for major projects in Singapore. In this role, you act as the primary technical authority for Commissioning and Qualification (C&Q), ensuring that all infrastructure meets the rigorous standards required for pharmaceutical manufacturing. You take ownership of the validation lifecycle from initial protocol generation through to final execution, navigating both Greenfield and Brownfield environments to ensure facility readiness and regulatory compliance.
Key Responsibilities
- Act as Subject Matter Expert (SME) for E/F/U C&Q, providing technical leadership on system boundaries and qualification strategies.
- Lead Protocol Lifecycle by coordinating, generating, reviewing, and executing IQ, OQ, and PQ protocols for critical systems.
- Manage Deviations & Investigations by leading root cause analysis and ensuring technica...
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