Job Responsibilities
- Lead and support Change Control activities for equipment and facility modifications, ensuring timely implementation and closure.
- Raise, investigate and manage Quality Events / Deviations, including root cause analysis and timely closure of investigations.
- Develop and implement Corrective and Preventive Actions (CAPA) arising from deviation investigations.
- Troubleshoot production equipment and process issues to identify technical causes and implement appropriate solutions.
- Support commissioning and qualification activities for new and modified equipment within Cell Culture and Purification manufacturing areas.
- Draft, review and execute commissioning and qualification documentation and protocols.
- Review engineering documentation including P&IDs, User Requirement Specifications (URS), functional specifications and technical drawings.
- Coordinate with Automation, Manufacturing and MSAT teams on process improvements, equipment changes and technical initiatives.
- Work closely with engineering consultants and cross-functional teams on new equipment installations and modifications.
- Support Validation activities, including execution of IQ, OQ and PQ protocols.
- Ensure timely closure of EHS and Quality investigations and associated CAPA actions.
- Ensure engineering activities comply with cGMP, Good Engineering Practices (GEP), EHS requirements and applicable quality standards.
- Participate as the Process Engineering representative in cross-functional meetings and projects.
Requirements
- Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Mechanical Engineering or a related engineering discipline.
- Minimum 3-5 years of relevant experience in pharmaceutical or biopharmaceutical manufacturing.
- Prior pharmaceutical / biopharmaceutical industry experience is required.
- Hands-on experience managing Change Controls, Deviations and CAPA within a cGMP environment..
- Good communication and stakeholder management skills with the ability to work effectively across Engineering, Manufacturing, Automation, MSAT and Validation teams.
Interested candidates are invited to email your resume to:
[Confidential Information]
Jenalyn Ooi Huai Sian (R1765551)
Recruit Express Pte Ltd
Company Reg. No. 199601303W
EA Licence No. 99C4599
