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Experience
Some experience
About the role
The manufacturing team is growing and needs an Associate Engineer to help run routine downstream biopharmaceutical production, keeping processes steady and reliable. You will work within a defined process scope, reporting to the Senior Manager, Manufacturing, and collaborating with cross-functional teams. This role suits someone with a few years of regulated manufacturing experience who enjoys monitoring data, solving problems, and improving how things run.
What you'll do
Support daily downstream manufacturing operations within the assigned scope.
Track critical process parameters, trends, and performance indicators to keep operations inside control limits.
Spot deviations, abnormalities, or drift, record what you see, and raise issues promptly.
Give day-to-day technical support to Manufacturing Operations on downstream process execution.
Serve as operational process SME for assigned downstream unit operations, helping keep performance safe, compliant, and consistent.
Help update downstream SOPs, batch records, and process documentation for new or changed processes.
Review and trend downstream process data to find variability, recurring problems, or improvement chances.
Support process improvements that boost robustness, yield, consistency, or reliability.
Work with MSAT and Automation teams on digital tools and process data.
Assist NPI and startup activities such as engineering runs, PPQ, or startup manufacturing, including data collection, verification, and documentation.
Take part in downstream process risk assessments like FMEA by gathering information and tracking actions.
Join process-related deviations and investigations, escalating complex matters to Senior Engineers.
Carry out assigned tasks in line with GMP, EHS, and site rules.
Help with audit and inspection readiness through accurate, timely documentation.
Suggest improvements for downstream process robustness, control, or execution.
Participate in OE, Lean, or continuous improvement efforts for downstream manufacturing.
Good to know
Location: Tuas, Singapore.
Full-time position.
Requirements
Diploma or Bachelor's degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or a related field.
3–4 years of experience in downstream biopharmaceutical manufacturing, process support, or manufacturing operations in a regulated setting.
Basic understanding of downstream biopharmaceutical processes such as seed train, cell culture, bioreactor operations, multi-column chromatography, and viral inactivation.
Working knowledge of GMP requirements and process data integrity principles.
Basic data analysis and trending skills for process performance monitoring.
Able to work well in cross-functional teams with appropriate guidance.
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