This position will report to the Aseptic Processing Functional Manager and will provide technical specialist support to all aseptic processing activities in the manufacture of Erwinase, Anthrax vaccine and other PBL products. The role will work cross functionally and be involved in current projects, new projects and all manufacturing activities that require aseptic processing input. It is expected that the role will typically focus on day to day aseptic processing matters within Production but may also be required to support projects designed to improve and develop PBL’s aseptic processing strategy.
We are looking for…
An individual who is educated to degree level or equivalent in a relevant discipline. The successful candidate should have a minimum of 5 years’ experience within Biopharma / Pharma aseptic GMP environments and have an in depth understanding of aseptic processing and techniques. You will need to have an understanding of regulatory requirements for biological products and experience in the implementation of new technologies and equipment into GMP manufacture and will have proven experience of generating GMP documents within a quality system. Experience of delivering specialised technical training and report writing and data trending evaluation would be desirable but not essential. The successful applicant will have a flexible approach to work and be able to deliver to schedules.
The post holder will…
- Lead in the day to day aseptic processing of PPL’s products.
- Support the management and development of improved and new processing techniques in the various aseptic processing activities.
- Provide technical support to production staff involved in the various aseptic processes.
- Provide troubleshooting and technical support into process investigations.
- Collate and share technical information with internal and external bodies to benefit the production methods, teams and departments.
- Perform process mapping and process efficiency trending.
- Provide specialist training to staff in aseptic processing techniques and theory.
- Identify, evaluate and adapt new technologies where appropriate and ensure that the production area operates to a high standard and complies with GMP and other regulatory standards.
- Assist colleagues in providing technical specialist input as required, in developing production and technical strategies for the units, identifying new opportunities as they arise and responding to external queries and complaints.
- Contribute to reports and assist on the preparation of presentations, publications and liaison with customers, collaborators and licensing agencies.
- Support the Functional Manager Aseptic Processing in pursuance of strategic improvements to aseptic processing control.