Editorial summary

The company is seeking a Process Engineer specializing in pharmaceutical manufacturing to oversee change control activities, manage quality events and deviations, and implement CAPA procedures. The role involves troubleshooting production equipment, supporting commissioning and qualification of new and modified equipment within cell culture processes. Candidates should have relevant experience in process engineering within the pharma industry. The position offers a salary of 8,500.

This summary is AI-generated and may contain inaccuracies. Please refer to the full job description below.

Job description

[This job id 28171 first appeared in Job-Q.com on 28 Aug 2026]

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:

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

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