About our client: Our client is a leading global pharmaceutical company.
About the role:
- Execute commissioning, qualification, and validation activities for HVAC systems and cleanrooms (Grade C & D) in accordance with EU GMP Annex 1, ISO 14644, and company quality requirements.
- Develop and execute HVAC and cleanroom qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Perform qualification activities for HVAC systems, AHUs, ducting, controls, HEPA filtration systems, temperature and humidity control systems, pressure control systems, and cleanrooms.
- Conduct and review cleanroom certification testing, including airflow visualization (smoke studies), air velocity measurement, air change rate calculations, HEPA filter integrity testing, non-viable particle monitoring, room pressurization verification, and temperature/humidity mapping.
- Support FAT, SAT, commissioning, and requalification activities.
- Manage deviations, change controls, punch lists, and qualification reports.
- Coordinate with QA, Engineering, Operations teams, contractors, and other stakeholders to ensure successful completion of qualification activities.
- Support cleanroom qualification and requalification programmes for GMP manufacturing facilities.
- Review technical documents, qualification records, and validation reports to ensure compliance with project and regulatory requirements.
About you:
- Bachelor's Degree in Mechanical Engineering, Chemical Engineering, Building Services Engineering, or related disciplines.
- Minimum 5 years of HVAC / Cleanroom CQV experience in pharmaceutical or biotechnology facilities.
- Strong knowledge and experience in EU GMP Annex 1, ISO 14644 Cleanroom Standards, ISPE Baseline Guides, and Good Documentation Practices (GDP).
- Proven experience in qualification of HVAC systems and cleanrooms within GMP-regulated environments.
- Experience with sterile manufacturing facilities and aseptic processing environments (e.g. isolators) will be highly advantageous.
- Familiarity with EMS/BMS systems and HVAC automation controls.
- Experience leading cleanroom qualification and requalification programmes.
- Strong technical writing and report preparation skills.
- Good problem-solving and troubleshooting abilities with strong attention to detail.
- Effective communication and stakeholder management skills.
- Ability to work independently and collaborate effectively within multidisciplinary teams.
- Strong planning, organisation, and time-management skills.
Other:
- Employment Type: Contract
- Work Schedule: 5 days per week
- Location: Tuas, Singapore
.Please note that only shortlisted candidates will be contacted..
Employment Agency: Kingsforce Management Services Pte. Ltd.
Employment Agency Licence No: 94C3545
EA Personnel: Kimberly Wong
EA Personnel Reg. No.: R1984508
