Manufacturing Operations Specialist

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

ROLE OVERVIEW

The Manufacturing Operations Specialist will provide hands-on operational and documentation support for single-usesystems within a GMP-regulated biopharmaceutical manufacturing environment. Acting as a shared resource acrossSingle-Use Operations and New Product Introduction teams, the role will support routine manufacturing activities andfacility-expansion projects, including shop-floor troubleshooting, system readiness, change-control coordination, andGMP documentation.

KEY RESPONSIBILITIES

• Provide day-to-day operational support for single-use systems, assemblies, and consumables used within the manufacturingarea.
• Support the set-up, installation, and operational readiness of single-use equipment and process assemblies on the manufacturing floor.
• Respond to time-sensitive issues involving leaks, integrity failures, connection problems, damaged components, and othersingle-use defects.
• Support investigations by gathering evidence, assessing potential causes, and coordinating follow-up actions with relevantstakeholders.
• Participate in an on-call rotation and provide responsive support within a 24/7 manufacturing environment.
• Initiate and progress change controls for facility expansion, process improvements, equipment changes, and departmentalactivities from impact assessment through closure.
• Prepare, review, and update SOPs, work instructions, single-use process diagrams, process system diagrams, and supportingtechnical documentation.
• Support deviations, investigations, CAPAs, and other quality-system records relating to single-use operations.
• Review single-use diagrams and process information to confirm configurations are suitable for their intended manufacturinguse.
• Coordinate operational-readiness, documentation, and handover activities across Operations, NPI, Quality, Engineering, Validation, Supply Chain, and vendors.
• Maintain complete, traceable, and inspection-ready records in accordance with GMP, Good Documentation Practices, and data-integrity requirements.
• Identify opportunities to improve the reliability, usability, and standardisation of single-use systems and associatedoperational processes.

CANDIDATE REQUIREMENTS

• Bachelor's degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Science, or a related discipline.
• Approximately five years of relevant experience within a GMP-regulated biotechnology, biopharmaceutical, or pharmaceuticalmanufacturing environment.
• Practical experience supporting site-based manufacturing operations and responding to time-sensitive shop-floor issues.
• Proven experience managing change controls, including initiation, impact assessment, implementation, action coordination, and closure.
• Strong GMP documentation experience covering deviations, investigations, CAPAs, SOPs, and controlled-document revisions.
• Able to interpret process documentation, technical diagrams, and equipment or system information.
• Strong attention to detail, organisation, communication, and cross-functional stakeholder-management skills.
• Willing and able to participate in a 24/7 on-call support rotation.

PREFERRED EXPERIENCE

• Drug-substance manufacturing experience and knowledge of end-to-end biopharmaceutical processes.
• Hands-on exposure to single-use bags, tubing assemblies, connectors, filters, manifolds, transfer assemblies, or relatedconsumables.
• Experience preparing or interpreting single-use process diagrams and process system diagrams.
• Previous involvement in NPI, technology transfer, facility expansion, manufacturing readiness, or single-use defectinvestigations.

CMC is an equal opportunity employer.

We welcome applications from individuals of all ages and backgrounds and assess candidates solely on merit, skills, and potential.

No terminology in this advert is intended to discriminate in any way.

We welcome applications/enquiries from individuals of all backgrounds and are committed to providing equal access to employment opportunities across all regions in which we operate.