GMP Biotech Commissioning & Qualification Lead

Anter Consulting Pte. Ltd.

Singapore

On-site

SGD 90,000 - 130,000

Full time

8 days ago
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Job summary

Anter Consulting Pte. Ltd. seeks an experienced Biotechnologist in Singapore to support a major capacity expansion at a GMP vaccine manufacturing site.

The role starts with hands-on commissioning and IQ/OQ execution, advancing through qualification into routine production while ensuring ongoing GMP operations remain uninterrupted. You will work with vendors, engineering, automation and QA to drive commissioning, qualification and documentation from day one, balancing critical qualification tasks

Qualifications

  • 3–10 years' hands-on experience in GMP biologics or vaccine manufacturing.
  • Experience with commissioning and qualification, specifically IQ/OQ.
  • Degree in Biotechnology, Bioprocess, Chemical Engineering, Life Sciences or related field.

Responsibilities

  • Commission and qualify new media and buffer systems, including SAT support and loop checks.
  • Execute IQ and OQ protocols, manage punch lists and deviations.
  • Support PQ and media hold-time studies through GMP release.
  • Coordinate with vendors, engineering, automation and QA from commissioning to handover.
  • Prepare media and buffers to approved recipes and perform aseptic transfers.

Skills

GMP Biologics
Commissioning & IQ/OQ
Media & Buffer Preparation
DeltaV Automation
Documentation

Education

Biotechnology / Bioprocess / Chemical Engineering degree

Tools

DeltaV
MES
Electronic Batch Records

Job description

Anter Consulting Pte. Ltd. seeks an experienced Biotechnologist in Singapore to support a major capacity expansion at a GMP vaccine manufacturing site.

The role starts with hands-on commissioning and IQ/OQ execution, advancing through qualification into routine production while ensuring ongoing GMP operations remain uninterrupted. You will work with vendors, engineering, automation and QA to drive commissioning, qualification and documentation from day one, balancing critical qualification tasks

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