Process Lead- BioPharma

EFOR (formerly Process Engineering Specialists); Singapore; On-site; SGD 120,000 - 190,000; Full time

Job summary

PES International is seeking a Process Lead to provide technical ownership and lead GMP-driven process engineering across CIP/SIP, washers, autoclaves, and related systems.

You will drive design activities, validation, and commissioning, partner with MS&T and Automation, and mentor cross-functional teams while ensuring reliability and efficiency in GMP manufacturing.

Qualifications

• Degree in Chemical, Mechanical, Pharmaceutical, Biotechnology Engineering or related discipline with pharma/GMP experience.
• Strong hands-on experience with CIP/SIP systems, automated process equipment, qualification/validation, troubleshooting and automation interfaces.

Responsibilities

• Provide technical ownership and process engineering support for CIP, SIP, washers, autoclaves, and GMP systems.
• Lead/support equipment and process design activities including P&IDs, URS, SRA/FRA, Design Reviews, DQ and HAZOP.
• Support FAT, SAT, commissioning, IQ, OQ, PQ, qualification, requalification and validation.
• Lead complex process troubleshooting, root cause analysis and engineering improvements to enhance reliability, yield, cycle time and operational efficiency.
• Optimise CIP/SIP cycles, equipment operating parameters and process performance, while minimising manufacturing and supply risks.
• Act as the technical interface between Process Engineering, MS&T and Automation.
• Lead/support Change Controls, Deviations, CAPAs, technical investigations and process-related risk assessments in a GMP environment.

Skills

Process engineering

CIP/SIP

HAZOP

FAT/SAT/commissioning

Qualification/validation

Troubleshooting

Cross-functional collaboration

Stakeholder management

Education

Chemical, Mechanical, Pharmaceutical, Biotechnology Engineering degree

Tools

P&IDs

URS

DQ/IQ/OQ/PQ

Job description

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.

With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational clients.

This focus, and our people's experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.

We are currently looking for Process Leady to join us on a permanent basis to help us deliver various projects in the Life Sciences Industry.

Key Attributes/Responsibilities:

• Provide technical ownership and process engineering support for CIP, SIP, washers, autoclaves, process vessels and associated GMP systems.
• Lead/support equipment and process design activities including P&IDs, URS, SRA/FRA, Design Reviews, DQ and HAZOP.
• Support FAT, SAT, commissioning, IQ, OQ, PQ, qualification, requalification and validation activities.
• Lead complex process troubleshooting, root cause analysis and engineering improvements to enhance reliability, yield, cycle time and operational efficiency.
• Optimise CIP/SIP cycles, equipment operating parameters and process performance, while minimising manufacturing and supply risks.
• Act as the technical interface between Process Engineering, MS&T and Automation, translating process requirements into recipes, parameters, sequences and equipment modules.
• Lead/support Change Controls, Deviations, CAPAs, technical investigations and process-related risk assessments in a GMP environment.
• Provide technical leadership to Manufacturing, Engineering and cross-functional teams, including support or deputising for the Engineering Lead where required.
• Degree in Chemical, Mechanical, Pharmaceutical, Biotechnology Engineering or related discipline, with strong pharmaceutical, biologics or GMP manufacturing experience.
• Strong hands-on experience with CIP/SIP systems, automated process equipment, qualification/validation, troubleshooting, automation interfaces and stakeholder management.

PES International operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.