Responsibilities:
- Plan, execute, and manage commissioning, qualification, and validation (CQV) activities for facilities, utilities, and process equipment.
- Develop and review CQV documentation, including IQ/OQ/PQ protocols and reports, in compliance with GMP and GAMP 5 standards.
- Coordinate with engineering, project, and quality teams to ensure timely and effective CQV execution.
- Troubleshoot and resolve CQV-related issues during project implementation.
- Ensure compliance with regulatory requirements (e.g., FDA, EMA, PIC/S) and applicable health authority guidelines.
- Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and risk assessments for new or modified systems.
- Provide technical input during design, construction, and operational readiness phases.
- Bachelor’s Degree in Engineering, Life Sciences, or related field.
- Minimum 2 years of experience in commissioning, qualification, and validation within the pharmaceutical / biotechnology / construction (modular) industry.
- Strong knowledge of GMP, GAMP 5, ISPE Baseline Guides, and related pharmaceutical regulations.
- Hands-on experience with utilities (e.g., WFI, clean steam, HVAC), process equipment, or cleanroom systems is an added advantage.
- Good communication, coordination, and problem-solving skills in a project-driven environment.
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EA Personnel Name: Felicia Chiam Kar Min
EA Personnel Reg. No.: R25152370
EA Licence No.: 07C5771