Biopharma Manufacturing Engineer: Single-Use Systems

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

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.