Biopharma Manufacturing Operations Specialist

Coalesce Management Consulting Pte. Limited; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Coalesce Management Consulting Pte. Limited is seeking a Manufacturing Operations Specialist to provide hands-on operational support and documentation for single-use systems in a GMP-regulated biopharma environment in Singapore. You will act as a shared resource across S.U.

Operations and NPI, supporting routine manufacturing and facility-expansion projects. You will manage shop-floor readiness, change-controls, and GMP documentation while coordinating with Quality, Engineering, and other

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Science or a related discipline.
• Approximately five years of relevant GMP-regulated biotechnology/pharma manufacturing experience.
• Experience supporting manufacturing operations in site-based environments.
• Proven experience managing change controls with initiation, impact assessment, action coordination, implementation and closure.
• Strong GMP documentation experience including deviations, investigations, CAPAs, SOPs and controlled-document revisions.
• Hands-on support on the manufacturing floor and responsiveness to time-sensitive issues.
• Ability to interpret process documentation and technical diagrams.
• Strong attention to detail, organisational skills and multi-priority management.
• Effective communication and stakeholder-management across multiple teams.
• Willingness to participate in a 24/7 on-call rotation.

Responsibilities

• Provide day-to-day operational support for single-use systems, assemblies and consumables.
• Assist with setup, installation and readiness of single-use equipment on the floor.
• Respond to shop-floor issues including leaks, integrity failures and connection problems.
• Support investigations by gathering information and coordinating actions.
• Participate in on-call rotation and provide 24/7 support.
• Initiate and progress change controls for facility expansion and process improvements.
• Assess impact of changes and coordinate actions through closure.
• Prepare, review and update GMP documentation including SOPs and diagrams.
• Support deviations, investigations, CAPAs and quality-system records.
• Review single-use diagrams to confirm suitability for manufacturing use.
• Coordinate activities across multiple stakeholders (SUE, NPI, Manufacturing, Quality, Engineering, Validation, Supply Chain).
• Support readiness and handover activities as expansion and NPI progress.
• Maintain traceable, inspection-ready GMP documentation.
• Identify opportunities to improve reliability and standardisation of single-use systems.

Skills

GMP documentation

Change controls

Single-use systems

Shop-floor operations

Cross-functional collaboration

On-call support

Process diagrams

Data integrity

Education

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

Job description

Coalesce Management Consulting Pte. Limited is seeking a Manufacturing Operations Specialist to provide hands-on operational support and documentation for single-use systems in a GMP-regulated biopharma environment in Singapore. You will act as a shared resource across S.U.

Operations and NPI, supporting routine manufacturing and facility-expansion projects. You will manage shop-floor readiness, change-controls, and GMP documentation while coordinating with Quality, Engineering, and other