Manufacturing Operations Specialist

Coalesce Management Consulting; Singapore; In loco; SGD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Coalesce Management Consulting is seeking a Manufacturing Operations Specialist to provide hands-on support for single-use systems within a GMP biopharma environment. You will coordinate change controls, assist with process documentation, and ensure equipment readiness on the manufacturing floor.

The role requires five years of relevant experience and a willingness to participate in a 24/7 on-call rotation.

Competenze

• Bachelor's degree in Engineering, Biotechnology, Life Sciences, or related field.
• Approximately five years of GMP-regulated biotech/pharma manufacturing experience.
• Experience supporting site-based manufacturing operations and time-sensitive shop-floor issues.
• Proven experience managing change controls from initiation to closure.
• Strong GMP documentation experience covering deviations, investigations, CAPAs, SOPs, and revisions.
• Ability to interpret process diagrams and equipment information.
• Detail-oriented with strong organisational, communication, and cross-functional skills.
• Willingness to participate in a 24/7 on-call rotation.

Mansioni

• Provide day-to-day operational support for single-use systems, assemblies, and consumables on the manufacturing floor.
• Set up, installation, and readiness of single-use equipment and process assemblies.
• Respond to leaks, integrity failures, and single-use defects.
• Coordinate investigations and follow-up actions with stakeholders.
• Participate in an on-call rotation in a 24/7 environment.
• Lead change controls from impact assessment to closure.
• Prepare and update SOPs, work instructions, and process diagrams.
• Support deviations, investigations, and CAPAs; maintain GMP records.
• Review single-use diagrams to confirm configurations for manufacturing use.
• Coordinate readiness and handover across multiple functions and vendors.

Conoscenze

GMP documentation

Change control management

Shop-floor troubleshooting

Cross-functional teamwork

On-call readiness

Process diagram interpretation

Attention to detail

Formazione

Bachelor's degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Science, or related discipline

Strumenti

Process diagrams

SOPs documentation

Descrizione del lavoro

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

KEY RESPONSIBILITIES

• Provide day-to-day operational support for single-use systems, assemblies, and consumables used within the manufacturing area.
• 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 other single-use defects.
• Support investigations by gathering evidence, assessing potential causes, and coordinating follow-up actions with relevant stakeholders.
• 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 departmental activities from impact assessment through closure.
• Prepare, review, and update SOPs, work instructions, single-use process diagrams, process system diagrams, and supporting technical 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 manufacturing use.
• 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 associated operational 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 pharmaceutical manufacturing 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 related consumables.
• 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 defect investigations.