Manufacturing Engineer

Anter Consulting; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

Anter Consulting is seeking a Manufacturing Engineer to support single-use system setup, use and inspection within a GMP biologics environment. You will ensure processes stay compliant and documentation remains current.

The ideal candidate has hands-on biopharmaceutical manufacturing experience, a keen eye for detail, and will own change controls and deviations from raise to closure while collaborating with Manufacturing, NPI and Quality teams.

Qualifications

• Minimum 5 years in GMP biologics/biopharmaceutical manufacturing.
• Strong knowledge of single-use systems and defect detection.
• Hands-on decontamination experience in manufacturing.
• Experience with change control processes.
• Experience authoring and investigating deviations.
• NPI documentation exposure is an advantage.

Responsibilities

• Support setup, use and inspection of single-use systems.
• Perform defect detection and integrity checks on SUS components.
• Carry out decontamination per site protocols.
• Update and maintain NPI documentation and SUDs.
• Raise, assess and progress change controls.
• Author and investigate deviations and drive CAPA.
• Liaise with Manufacturing, NPI and Quality to keep docs current.

Skills

GMP Biologics

Single-use systems

Change control

Deviation investigation

Documentation control

Job description

Job Description

We are hiring a Manufacturing Engineer to support single-use system (SUS) setup, use and inspection within a GMP biologics manufacturing environment. You will keep single-use processes compliant and documentation current.

The ideal Manufacturing Engineer has hands‑on experience in biopharmaceutical manufacturing and a strong eye for detail. You will work closely with Manufacturing, NPI and Quality teams, and you will own change controls and deviations from raise to closure.

Key Responsibilities

• Support the setup, use and inspection of single-use systems
• Perform defect detection and integrity checks on single-use assemblies and components
• Carry out decontamination of 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 for manufacturing and single-use processes
• Author and investigate deviations, driving root cause analysis and corrective actions
• Liaise with Manufacturing, NPI and Quality to keep documentation and processes current

Required Qualifications and Skills

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

Reference no.: 122-4948-2918-NW

Registration no.: 968446516E