Process Engineer

Tek Systems; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a skilled Process Engineer to support manufacturing operations. The candidate will leverage their technical expertise in troubleshooting, root cause analysis, and process improvement in a GMP-regulated environment to ensure compliance and robustness in production processes. This role involves analyzing process trends, driving technology transfers, and providing training to cross-functional teams.

Qualifications

• 3–4 years of relevant experience; Master’s with 2 years or fresh PhD in a related field also welcome.
• Practical experience in cell culture/Upstream and/or Downstream purification within a manufacturing or development setting.
• Strong knowledge of cGMP, deviation management.

Responsibilities

• Support and troubleshoot Upstream/Downstream manufacturing operations.
• Serve as SME for root cause analysis and process investigations.
• Lead or support technology transfer of new products and processes.

Skills

Process troubleshooting

Root cause analysis

Process improvement

Analytical skills

Communication

Education

Bachelor’s degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, or Biochemical Engineering

Job description

• Support and troubleshoot Upstream/Downstream manufacturing operations, resolving process or product issues as they arise.
• Serve as SME for root cause analysis (RCA), impact assessments, and process investigations to maintain product quality and compl
• Analyze and monitor process trends through the Continuous Process Verification (CPV) program; escalate and investigate any out-o

We are seeking a skilled Process Engineer with hands-on experience in supporting manufacturing operations to work with a pharmaceutical MNC. This role requires strong technical expertise in troubleshooting, root cause analysis, and process improvement in a GMP-regulated environment. You will act as a technical subject matter expert (SME), supporting manufacturing activities, driving technology transfers, and ensuring robust, compliant production processes.

The Position:

·Support and troubleshoot Upstream/Downstream manufacturing operations, resolving process or product issues as they arise.

·Serve as SME for root cause analysis (RCA), impact assessments, and process investigations to maintain product quality and compliance.

·Analyze and monitor process trends through the Continuous Process Verification (CPV) program; escalate and investigate any out-of-trend results.

·Plan and execute process improvements and robust projects to drive operational excellence

·Lead or support technology transfer of new products and processes, including evaluation of new manufacturing technologies or equipment.

·Draft and review technical documentation, including Master Batch Records, change controls, and validation protocols.

·Provide process training to cross-functional teams and support audits, regulatory submissions, and inspections.

The Candidate:

•Bachelor’s degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, or Biochemical Engineering, with 3–4 years of relevant experience; Master’s with 2 years or fresh PhD in a related field also welcome.

•Practical experience in cell culture/Upstream and/or Downstream purification within a manufacturing or development setting.

•Strong knowledge of cGMP, process troubleshooting, root cause analysis, and deviation management.

•Demonstrated ability to plan and execute process improvements, monitor process performance, and lead technology transfers.

•Excellent analytical skills, strong communication, and a collaborative, self-starting mindset.

•Comfortable working cross-functionally in a regulated, fast-paced biopharmaceutical manufacturing environment.

Preferred Qualifications

•Experience drafting and managing change controls, impact assessments, and validation documentation.

•Familiarity with CPV, statistical process monitoring, and continuous improvement methodologies.

•Proven ability to support audits, inspections, and regulatory submissions within a GMP environment.

We regret to inform that only shortlisted candidates will be notified / contacted.

EA Registration No.: LEE YAO HONG MALCOLM , R22109832

Allegis Group Singapore Pte Ltd, Company Reg No. 200909448N, EA License No. 10C4544