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
Single-Use Operations and New Product Introduction teams, the role will support routine manufacturing activities and
facility-expansion projects, 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.
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.