Contract Senior Process Engineer HJO

Job Responsibilities

• Lead and manage Quality Events / Deviations, including investigation, analysis and timely closure.
• Raise and manage Change Controls for modifications to manufacturing equipment and facilities.
• Develop and implement CAPA arising from deviation investigations and ensure timely completion.
• Troubleshoot process and equipment issues and provide technical support to manufacturing operations.
• Support commissioning and qualification of new and modified equipment within Cell Culture and Purification / Downstream processing areas.
• Draft, review and execute commissioning and qualification protocols and documentation.
• Coordinate with Manufacturing, Automation, MSAT, Validation and Engineering teams on equipment improvements and process changes.
• 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 and applicable quality requirements.

Requirements

• Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Mechanical Engineering or a related engineering discipline.
• Minimum 3-5 years of relevant experience within the pharmaceutical / biopharmaceutical industry.
• Pharmaceutical / biopharmaceutical manufacturing experience will be advantageous.
• Hands-on experience in Change Control and Deviation investigation and closure is required.
• Experience in upstream and/or downstream bioprocess operations downstream / purification experience is highly preferred.
• Good knowledge of biological drug substance manufacturing processes and process equipment.
• Good communication skills with the ability to work effectively across cross-functional 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