Technical Specialist

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

Technical Specialist

Target Onboarding: September 2026

Location: Singapore (Biopharmaceutical Manufacturing Operations)

Job Description

We are seeking a Technical Specialist to support our core biopharmaceutical manufacturing operations on a contract basis across three critical phases: Operational Readiness, Run, and Release . In this role, you will play a pivotal part in supporting seamless technology transfers, driving continuous operational reliability, and leading complex deviation investigations to ensure timely product release.

Key Responsibilities

• Operational Readiness

  Support technology transfers and process campaigns by developing and revising Master Batch Records (MBRs), Change Requests (CRs), and operational documentation.

  Manage operational risk assessments, facilitate pre-campaign training sessions, and ensure all readiness tasks are fully executed prior to campaign startup.

• Operational Run

  Support the evaluation of manufacturing deviations within the Deviation Review Board (DRB).

  Manage CAPAs, Change Control System Requests (CSCCs), rejected material processes, and associated campaign tasks.

  Participate actively in audits and quality reviews focused on manufacturing process and deviation topics.

• Operational Release

  Lead technical deviation investigations and trend analyses to identify root causes using structured problem-solving methodologies.

  Conduct precise product impact assessments and design effective CAPAs to support the timely disposition and release of manufactured lots.

Requirements

• Experience & Knowledge: Strong understanding of biopharmaceutical/pharmaceutical manufacturing processes and hands-on operational knowledge of manufacturing equipment.
• Technical Competencies: Proven experience in technical writing, root cause analysis (RCA), and managing Quality Management System (QMS) elements (Deviations, CAPAs, Change Controls).
• Soft Skills: Excellent verbal communication and presentation skills.
• Adaptability: High degree of agility to manage shifting deliverables and dynamic operational priorities.