Technical Specialist (Manufacturing Deviations) @ TUAS #HFT

Contract: 6 months (renewable / extendable)
Salary: Up to $7,000/month
Completion Bonus: 0.5-month completion bonus

Job Responsibilities

• Lead end-to-end manufacturing deviation investigations in a GMP-regulated biopharmaceutical environment.

• Own investigations from initiation and root cause identification through CAPA development, implementation and closure.

• Conduct Root Cause Analysis (RCA) using methodologies such as 5 Whys and Fishbone Analysis.

• Facilitate cross-functional investigations with Manufacturing, QA, QC, MSAT and Engineering teams.

• Assess manufacturing deviations, process discrepancies and potential product quality impacts.

• Develop and monitor CAPAs, including effectiveness checks to prevent recurrence.

• Prepare technical investigation reports, assessments and supporting GMP documentation.

• Track investigation timelines and drive timely closure of deviations and CAPAs.

• Support deviation trending, recurring issue investigations and continuous improvement initiatives.

• Ensure compliance with GMP requirements, internal SOPs and regulatory standards.

Job Requirements

• Diploma or Degree in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Life Sciences or a related discipline.

• Prior experience in biopharmaceutical or pharmaceutical manufacturing, preferably in biologics, vaccines, API or drug substance manufacturing.

• Strong hands-on experience independently leading end-to-end manufacturing deviation investigations is essential.

• Proven experience in RCA, CAPA management, product impact assessments and deviation closure.

• Good understanding of GMP manufacturing processes, production equipment and shop-floor operations.

• Experience working with cross-functional stakeholders to resolve manufacturing issues.

• Strong technical writing, analytical and problem-solving skills.

• Familiarity with TrackWise, Veeva Vault or other electronic quality management systems is advantageous.

• Able to manage multiple investigations independently and work in a dynamic manufacturing environment.

For interested candidates, please submit your latest resume to [email protected].

Jacqueline Fong Hsin Ting (R21103226)
Recruit Express Pte Ltd
Company Reg. No. 199601303W
EA License Number: 99C4599.