Process Engineer | Biopharmaceutical Manufacturing & GMP #HDC1

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; 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.
• Strong experience in Deviation / Quality Event investigation and Change Control management.
• Knowledge of downstream/purification processes is advantageous.

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.
• Represent Process Engineering in cross-functional technical meetings.
• Collaborate with Automation, Manufacturing and MSAT teams on improvements.
• Review technical documentation including P&IDs, URS, functional specifications, drawings and equipment turnover packages.
• Participate in equipment installation inspections and vendor turnover.
• Participate in software FAT activities, including PCS7, where applicable.
• Support and participate in C&Q activities for new and modified equipment.
• Review and execute C&Q documentation and support qualification activities including IQ, OQ and PQ.
• Work towards delivering projects and engineering activities right first time, while maintaining GMP, EHS and engineering standards.
• Perform other engineering duties and projects as assigned.

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

Drive Process Excellence Across Critical Biopharmaceutical Operations

We are seeking an experiencedProcess Engineerto support engineering and manufacturing activities within acGMP-regulated biopharmaceutical environment.

This role will work closely with Process Engineering, Manufacturing, MSAT, Automation, Maintenance and Validation teams to supportdeviation investigations, change controls, equipment commissioning, qualification and continuous improvement initiativesacross Cell Culture and Downstream/Purification operations.

If you have hands‑on experience supporting pharmaceutical or biopharmaceutical manufacturing and are confident managing technical investigations and engineering changes, this role offers an opportunity to contribute to complex manufacturing projects and critical process improvements.

What You’ll Be Responsible For

• Lead and manageQuality Events / Deviation investigations, ensuring timely creation, analysis, corrective actions and closure.
• LeadChange Controlsrelating to equipment and facility modifications, upgrades and improvements.
• Own and implementCAPA projectsarising from deviation investigations.
• Troubleshoot equipment issues and support fault-finding when systems operate outside expected parameters.
• Ensure timely completion of EHS and Quality investigations, CAPA activities and associated actions.
• Represent Process Engineering in cross-functional technical meetings and initiatives.
• Work closely withAutomation, Manufacturing and MSAT teamsto implement improvements and engineering changes.
• Collaborate with engineering consultants and project teams on new and modified equipment.
• Review technical documentation includingP&IDs, URS, functional specifications, drawings and equipment turnover packages.
• Participate in equipment installation inspections and vendor/construction turnover activities.
• Participate in software FAT activities, includingPCS7, where applicable.
• Support and participate inCommissioning & Qualification (C&Q)activities for new and modified equipment within Cell Culture and Downstream/Purification areas.
• Review and execute C&Q documentation and support qualification activities includingIQ, OQ and PQ.
• Work towards delivering projects and engineering activitiesright first time, while maintaining applicable GMP, EHS and engineering standards.
• Perform other engineering duties and projects as assigned.

What We’re Looking For

• Degree or relevant qualification inEngineering, Bioprocessing or a related discipline.
• 3–5+ years of relevant experiencein upstream/downstream bioprocess operations or equipment engineering within the pharmaceutical or biopharmaceutical industry.
• Experience supportingcGMP manufacturing operationsin a pharmaceutical or biopharmaceutical environment.
• Strong experience inDeviation / Quality Event investigation and Change Control management.
• Knowledge of biological drug substance manufacturing processes;downstream/purification experience is highly advantageous.
• Understanding of equipment commissioning, qualification stages and associated process activities.
• Strong knowledge ofcGMP and Good Engineering Practices (GEP).
• Familiarity with biopharmaceutical facility design principles and engineering standards.
• Knowledge of sanitary design requirements for biopharmaceutical manufacturing equipment.
• Strong troubleshooting, analytical and problem-solving capabilities.
• Good written and verbal communication skills, with the ability to work effectively across technical and cross-functional teams.

Why Consider This Opportunity?

Take on a hands‑on engineering role within aspecialised biopharmaceutical manufacturing environment, supporting critical equipment, process improvements, deviations, change controls and qualification activities.

You’ll gain exposure acrossCell Culture, Downstream/Purification, C&Q, GMP investigations and cross‑functional engineering projects, making this a strong opportunity for an engineer looking to deepen their expertise in biopharmaceutical manufacturing.