- 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 technical issues are resolved and closed on schedule.
- Uphold Regulatory Excellence by maintaining strict adherence to evolving global and local GMP regulations.
- Drive Project Milestones through proactive planning and cross-functional communication with Engineering, Quality, and Production teams.
- Execute Technical Validation tasks, potentially including SIP/Sterilization validation and leveraging digital tools like KNEAT.
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- 6 years of C&Q experience specifically within the Pharmaceutical or Life Sciences sectors.
- Proven experience in both Greenfield (Start-up) and Brownfield project environments.
- Deep knowledge of GMP standards and current regulatory requirements for equipment and utility validation.
- Ability to work as a self-managed, tenacious professional.
- Apply a methodical approach to managing deviations and complex technical investigations.
- Hands-on experience with SIP/Sterilization Validation (Kaye) or paperless validation systems such as KNEAT is a significant bonus.
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Validation Engineer - Singapore - Anter Consulting
Description
Job DescriptionThe 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
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Validation Engineer
Only for registered members Singapore
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Validation Engineer
Only for registered members Singapore
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Validation Engineer
Only for registered members Singapore
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Validation Engineer
Only for registered members Singapore
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Validation Engineer
Only for registered members Singapore
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Validation Engineer
Only for registered members Singapore
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Validation Engineer
Full time Flex- Singapore
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Validation Engineer
Amaris Consulting- Singapore
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Validation Engineer
Only for registered members West Region
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CSV Validation Engineer
Coalesce Management Consulting- Singapore
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CSV Validation Engineer
Only for registered members Singapore
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Validation Engineer Intern
Only for registered members Singapore
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EFU Validation Engineer
Only for registered members Singapore, Singapore, Singapore
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Systems Validation Engineer
Only for registered members Singapore
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Systems Validation Engineer
Only for registered members Singapore
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EFU Validation Engineer
Only for registered members Singapore
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Systems Validation Engineer
Only for registered members Singapore River
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Junior Validation Engineer
Only for registered members Singapore
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Cleaning Validation Engineer
Only for registered members Singapore
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CSV Validation Engineer
Only for registered members Singapore
