Biopharma Process Engineer: Deviation & Change Controls

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Recruit Express Pte Ltd is seeking an experienced Process Engineer to support engineering and manufacturing in a cGMP-regulated biopharmaceutical environment.

You will work with Process Engineering, Manufacturing, MSAT, Automation, Maintenance and Validation teams on deviations, change controls, commissioning, qualification and continuous improvement initiatives across Cell Culture and Downstream/Purification ops.

Qualifications

• Degree in engineering or related discipline with biopharma exposure.
• Experience in Deviation investigations, Change Controls and CAPA.
• Familiarity with cGMP in biopharma manufacturing environments.

Responsibilities

• Lead deviation investigations and ensure timely corrective actions.
• Manage change control activities for equipment and facilities.
• Support CAPA execution and associated investigations.
• Troubleshoot equipment issues and assist in fault finding.
• Collaborate with Automation, MSAT, Manufacturing and QA teams.

Skills

Process engineering

Quality investigations

Change control

CAPA

GMP

Biopharma

Troubleshooting

Cross-functional collaboration

Education

Engineering degree

Bioprocessing knowledge

Tools

PCS7

Validation tools

Job description

Recruit Express Pte Ltd is seeking an experienced Process Engineer to support engineering and manufacturing in a cGMP-regulated biopharmaceutical environment.

You will work with Process Engineering, Manufacturing, MSAT, Automation, Maintenance and Validation teams on deviations, change controls, commissioning, qualification and continuous improvement initiatives across Cell Culture and Downstream/Purification ops.