Single-Use Manufacturing Ops Specialist (24/7 On-Call)

Coalesce Management Consulting; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Coalesce Management Consulting is seeking a Manufacturing Operations Specialist for a GMP-regulated biopharmaceutical environment in Singapore.

You will provide hands-on support for single-use systems, drive change-controls from assessment to closure, maintain GMP-compliant records, and coordinate with Quality, Engineering, and NPI to enable manufacturing readiness.

The role requires 5 years of GMP experience and a track record of cross-functional collaboration in manufacturing operations.

Qualifications

• Bachelor’s degree in a relevant discipline.
• Approximately five years of GMP-regulated biotechnology/pharma manufacturing experience.
• Experience managing change controls from initiation to closure.
• Strong GMP documentation experience including deviations, investigations, CAPAs, SOPs.

Responsibilities

• Provide day-to-day operational support for single-use systems, assemblies, and consumables in the manufacturing area.
• Support setup, installation, and readiness of single-use equipment on the manufacturing floor.
• Respond to time-sensitive shop-floor issues (leaks, integrity failures, connection problems, defects).
• Coordinate investigations by gathering evidence and coordinating follow-up actions with stakeholders.
• Participate in a 24/7 on-call rotation and provide responsive support.
• Initiate and progress change controls for facility expansion and process improvements from assessment to closure.
• Prepare, review, and update SOPs, work instructions, and supporting documentation.
• Support deviations, investigations, CAPAs, and other quality-system records.

Skills

GMP documentation

Cross-functional collaboration

Change-control management

Attention to detail

Communication

On-call readiness

Education

Bachelor's degree in Engineering/Biotech/Life Sciences/Pharmaceutical Science

Job description

Coalesce Management Consulting is seeking a Manufacturing Operations Specialist for a GMP-regulated biopharmaceutical environment in Singapore.

You will provide hands-on support for single-use systems, drive change-controls from assessment to closure, maintain GMP-compliant records, and coordinate with Quality, Engineering, and NPI to enable manufacturing readiness.

The role requires 5 years of GMP experience and a track record of cross-functional collaboration in manufacturing operations.