Upstream Bioprocess Operations Engineer for GMP Vaccine

ANTER CONSULTING PTE. LTD.

Singapore

On-site

SGD 90,000 - 150,000

Full time

10 days ago

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

ANTER CONSULTING PTE. LTD. is seeking an Operations Engineer focused on upstream manufacturing for a vaccine facility expansion in Singapore.

You will help introduce new upstream equipment, materials and processes, working with manufacturing, engineering, automation and quality teams in a GMP environment. You will perform hands-on commissioning, qualification, process validation and technical support, with emphasis on IQ/OQ execution, PPQ protocols and deviation investigations.

Qualifications

Bachelor's degree in Chemical/Bioprocess/Biochemical Engineering or related field.
At least 3 years' GMP biologics or vaccine manufacturing experience with upstream focus.
Hands-on commissioning and IQ/OQ execution for manufacturing equipment.
Experience authoring/ executing PPQ protocols.
Proven deviation investigations and CAPA with root cause analysis.
Familiarity with change control and impact on validated equipment.

Responsibilities

Support commissioning of upstream equipment including bioreactors and transfer systems.
Execute IQ/OQ protocols and document deviations or amendments.
Assist in validation activities and process performance qualifications.
Provide technical support for seed train, cell culture, and bioreactor operations.
Monitor process parameters, review batch trends and investigate issues.
Coordinate with engineering, automation, quality and vendors for handover and project delivery.
Update batch records and SOPs; participate in change controls and CAPA.
Assist in commissioning/troubleshooting CIP/SIP systems and clean utilities interfaces.