Manufacturing Operations Specialist

Role Overview

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 the Single-Use Operations and New Product Introduction teams, the role will support routine manufacturing activities and facility-expansion projects. Key areas of responsibility include shop-floor troubleshooting, single-use system readiness, change-control coordination and the preparation and maintenance of 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 shop-floor issues involving single-use systems, including leaks, integrity failures, connection issues, damaged components and other operational defects.

• Support the investigation of single-use-related events by gathering information, 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, coordinate and progress change controls associated with facility expansion, process improvements, equipment changes and departmental activities.

• Assess the operational and documentation impact of proposed changes and coordinate required actions through implementation and closure.

• Prepare, review and update GMP-controlled documentation, including SOPs, work instructions, single-use process diagrams, process system diagrams and supporting technical documents.

• Support the preparation and closure of deviations, investigations, CAPAs and other quality-system records relating to single-use operations.

• Review single-use diagrams and process information to confirm that proposed system configurations are suitable for their intended manufacturing use.

• Coordinate activities and documentation deliverables across Single-Use Operations, NPI, Manufacturing, Quality, Engineering, Validation, Supply Chain and other project stakeholders.

• Support operational readiness, documentation readiness and manufacturing handover activities as facility-expansion and NPI activities progress.

• Maintain accurate, traceable and inspection-ready documentation 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 manufacturing operations within a site-based or shop-floor environment.

• Proven experience managing change controls, including initiation, impact assessment, action coordination, implementation and closure.

• Strong GMP documentation experience, including deviations, investigations, CAPAs, SOPs and controlled-document revisions.

• Comfortable providing hands-on support and responding to time-sensitive operational issues on the manufacturing floor.

• Able to interpret process documentation, technical diagrams and equipment or system information.

• Strong attention to detail, organisation and ability to manage multiple operational and documentation priorities.

• Effective communication and stakeholder-management skills, with the ability to work across Operations, Quality, Engineering and project teams.

• Willing and able to participate in a 24/7 on-call support rotation.

Preferred Experience

• Experience supporting drug-substance manufacturing operations and an understanding of end-to-end biopharmaceutical manufacturing processes.

• Hands-on exposure to single-use technologies, including bags, tubing assemblies, connectors, filters, manifolds, transfer assemblies or related consumables.

• Experience interpreting or preparing single-use process diagrams and process system diagrams.

• Previous involvement in New Product Introduction, technology transfer, facility expansion or manufacturing-readiness projects.

• Experience investigating leaks, integrity failures or other single-use system defects within a manufacturing environment.

Why Join This Opportunity?

• Take on a visible role supporting both routine manufacturing operations and a major facility expansion.

• Gain cross-functional exposure across Single-Use Operations, NPI, Manufacturing, Quality and Engineering.

• Contribute directly to operational readiness, manufacturing reliability and the successful implementation of new processes and systems.