Manufacturing Engineer

ANTER CONSULTING PTE. LTD.; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

ANTER CONSULTING PTE. LTD. is seeking an experienced professional to support the setup, use, and inspection of single-use systems in a biologics manufacturing environment. You will perform defect detection, decontamination, and maintain NPI documentation, including SUDs and schematics.

You will raise and progress change controls for manufacturing and SUS, author and investigate deviations, and drive root cause analysis with cross-functional teams to ensure documentation stays current.

Qualifications

• Minimum ~5 years' experience in a biologics/biopharmaceutical GMP environment.
• Solid working knowledge of single-use systems/technology, including defect detection.
• Manufacturing background with hands-on decontamination experience.
• Demonstrated experience with change control processes.
• Demonstrated experience authoring/investigating deviations.
• Exposure to NPI documentation an advantage.

Responsibilities

• Support single-use system (SUS) setup, use, and inspection within a biologics manufacturing environment.
• Perform defect detection and integrity checks on single-use assemblies and components.
• Carry out decontamination procedures for equipment, materials, and manufacturing areas per site protocols.
• Update and maintain NPI documentation, including single-use diagrams (SUDs) and related schematics.
• Raise, assess, and progress change controls related to manufacturing and single-use processes.
• Author and investigate deviations, driving root cause analysis and corrective actions.
• Liaise cross-functionally with Manufacturing, NPI, and Quality to ensure documentation and processes stay current.

Skills

Single-use tech

GMP Biologics

Decontamination

Change control

Deviation investigation

Job description

Roles &Responsibilities

• Support single-use system (SUS) setup, use, and inspection within a biologics manufacturing environment
• Perform defect detection and integrity checks on single-use assemblies and components
• Carry out decontamination procedures for equipment, materials, and manufacturing areas per site protocols
• Update and maintain NPI documentation, including single-use diagrams (SUDs) and related schematics
• Raise, assess, and progress change controls related to manufacturing and single-use processes
• Author and investigate deviations, driving root cause analysis and corrective actions
• Liaise cross-functionally with Manufacturing, NPI, and Quality to ensure documentation and processes stay current

Requirements

• Minimum ~5 years' experience in a biologics/biopharmaceutical manufacturing environment (GMP)
• Solid working knowledge of single-use systems/technology, including defect detection
• Manufacturing background with hands‑on decontamination experience
• Demonstrated experience with change control processes
• Demonstrated experience authoring/investigating deviations
• Exposure to NPI documentation an advantage