Biopharma Technical Specialist - Operations & Release

ANTER CONSULTING PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

ANTER CONSULTING PTE. LTD. is seeking a Technical Specialist to support core biopharmaceutical manufacturing operations on a contract basis across Operational Readiness, Run, and Release phases in Singapore.

You will help drive technology transfers, improve operational reliability, and lead deviation investigations to ensure timely product release. The role requires hands-on experience with manufacturing processes and equipment, strong technical writing, and proficiency in quality systems.

Qualifications

• Experience in biopharmaceutical manufacturing and hands-on equipment operation.
• Proven RCA, QMS management including Deviations, CAPAs, and Change Controls.
• Strong communication and presentation skills.
• Ability to manage shifting priorities in a contract setting.

Responsibilities

• Assist Operational Readiness activities and maintain MBRs, CRs, and documentation.
• Support DRB evaluation, CAPA management, CSCCs, and audits.
• Lead investigations into deviations and ensure timely disposition and release of lots.

Skills

Root cause analysis

Technical writing

Quality Management System

CAPAs

Change controls

Deviations

Process validation

Tools

CSCCs (Change Control System)

Job description

ANTER CONSULTING PTE. LTD. is seeking a Technical Specialist to support core biopharmaceutical manufacturing operations on a contract basis across Operational Readiness, Run, and Release phases in Singapore.

You will help drive technology transfers, improve operational reliability, and lead deviation investigations to ensure timely product release. The role requires hands-on experience with manufacturing processes and equipment, strong technical writing, and proficiency in quality systems.