- 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 34 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
