AddressIntroduction to role
This post is part of the team responsible for the fermentation, extraction and downstream processing of Erwinase as well as the manufacture of Anthrax Vaccine (AV).
As part of the manufacturing activities, the team is responsible for the preparation of required materials, solutions and equipment and the operation of a variety of production equipment. The team will work within an MHRA licensed manufacturing facility, consisting of several cleanrooms.
Day to day tasks also include maintaining the manufacturing cleanroom areas via specialist cleaning and disinfection procedures and monitoring the environmental conditions.
All activities are performed in accordance with current Good Manufacturing Practice (cGMP).
The team works across the manufacturing facilities based at the Fermentation Process Plant (FPP) and the Therapeutic Proteins Unit (TPU) or on the main site manufacturing the Anthrax Vaccine (AV).
This role is a flexible role working unsociable hours and on occasions night working as part of the contract during the production campaigns. Shift working during campaigns consists of Monday-Friday, on a rota of early, mid and late shifts and the expectation of the Production Operator role is to cover this shift pattern
Key Responsibilities
- Carry out duties involved in the manufacture of Erwinase and AV, to cGMP requirements as directed, ensuring that product/materials are manufactured to appropriate regulatory requirements and in adherence to the production schedule.
- Work within the site Quality System, adhering to all policies, procedures, rules, regulations and guidelines and reporting any non-compliance promptly.
- Ensure that the manufacturing facilities are maintained in a safe, clean and compliant state at all times, executing specialist cleaning and disinfection procedures and a range of environmental monitoring techniques.
- Undertake all necessary training to enable all duties to be carried out to the required standard, ensuring full compliance with PBL Codes of Practice (COPs) and Standard Operating Procedures (SOPs).
- Undertake work in accordance with PBL Health and Safety Policies and Procedures, protecting self and others at all times and reporting hazards/near misses promptly.
- Perform a wide range of technical procedures and understand the rationale behind all procedures and practices
- Show diligence and attention to detail to all tasks and complete all documentation accurately and to a high standard.
- Keep clear and accurate records of all Production activities via Batch Manufacturing Records (BMRs) and logbooks
- Operate a variety of specialised equipment and maintain via a range of processes for cleaning and sterilisation.
- Ensure provision of raw materials and disposable equipment for production use and managing local stock rotation.
Personal Specification
Current, valid Right to Work in UK
Experience of working in a manufacturing environment, cleanroom or related industry is desirable
