Role Overview
A leading biopharmaceutical manufacturing organisation is seeking an Upstream Bioprocess Associate to join its Manufacturing Operations team on a contingent basis.
Reporting to the Shift Lead, the successful candidate will support day-to-day manufacturing activities within a large-scale biopharmaceutical facility, alongside commissioning, qualification, and validation activities for process equipment and systems.
This position operates within a continuous manufacturing environment and requires participation in a 24/7 shift rota.
Key Responsibilities
- Execute commercial-scale manufacturing processes in accordance with approved procedures, work instructions, and established quality standards.
- Develop, review, and update standard operating procedures and other manufacturing documentation.
- Operate and monitor production equipment within the designated manufacturing area.
- Ensure compliance with Good Manufacturing Practice (GMP), standard operating procedures, and applicable regulatory requirements.
- Participate in process investigations, troubleshooting, and optimisation activities using scientific, engineering, and Lean methodologies.
- Utilise process control, manufacturing execution, data historian, and other relevant business systems to support manufacturing operations.
- Assist with the review of batch records, manufacturing reports, and process exceptions in collaboration with Quality Assurance, contributing to investigations and audit-related activities where required.
- Collaborate with Manufacturing Operations, Engineering, Commissioning, Qualification and Validation (CQV), Automation, and Computer Systems Validation teams to support facility implementation, equipment qualification, process validation, and operational readiness.
- Contribute to a culture of continuous improvement and operational excellence by identifying and implementing improvements to processes, equipment performance, and workplace safety.
- Promote a safe working environment while maintaining high standards of quality, compliance, and operational performance.
Candidate Requirements
The ideal candidate will demonstrate the following:
- A minimum Level 6 qualification in Engineering, Science, or a related technical discipline. Equivalent relevant industry experience may also be considered.
- At least three years of experience working within a large-scale biopharmaceutical manufacturing environment.
- Experience working in a regulated manufacturing setting, ideally within a current Good Manufacturing Practice (cGMP) environment or a comparable controlled cleanroom industry.
- Familiarity with process automation, manufacturing execution systems (MES), and associated process monitoring and data acquisition technologies.
- Strong problem-solving and analytical skills, with the ability to investigate issues and contribute to effective solutions.
- The ability to work independently while collaborating effectively within multidisciplinary teams.
- Strong communication and organisational skills, with the ability to manage priorities and meet scheduled deadlines in a fast-paced environment.
- A proactive approach to continuous improvement, operational excellence, and maintaining a high standard of quality and safety.
Working Arrangements
Due to the nature of the manufacturing operation, this role requires flexibility to work shifts within a 24/7 production environment.
