Process Engineer (Pharma Manufacturing) #HJO

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:

[email protected]

Jenalyn Ooi Huai Sian (R1765551)
Recruit Express Pte Ltd
Company Reg. No. 199601303W
EA Licence No. 99C4599