PRODUCTION OPERATOR

Introduction to role

An exciting opportunity has arisen for a Production Operator to join Porton Biopharma, a leading biopharmaceuticals company located on the historic Porton Down site, in the picturesque countryside of Salisbury, Wiltshire.

Porton Biopharma Limited (PBL) is a limited liability company, established in 2015, to commercialise pharmaceutical development and manufacturing capabilities.  Our mission is to protect patients’ health through the quality-assured development and production of biopharmaceuticals.  We develop new vaccines, therapeutic proteins, and enzyme products, and manufacture our own licensed biopharmaceutical products, Erwinase® and the UK’s Anthrax Vaccine.

We offer specialist expertise in the development of both manufacturing and analytical processes for use with biological pharmaceutical products. Particularly in taking concepts from the research laboratory and progressing them through the various stages of scale-up and process development to manufactured product for licensed supply or clinical trial.

Our employees join us safe in the knowledge that their skills and experience are contributing to a valuable purpose. This is an excellent environment for the right person to build their biopharmaceutical career.

The Production Operator will be in receipt of a competitive benefits package, including:

• 30 days of holiday, plus 8 bank holidays.
• On the job training, and genuine opportunities for growth and advancement.
• Generous pension scheme.
• Access to online discounts.
• A work environment based in the beautiful Salisbury countryside, with free on-site parking, easy access to London and the south coast
• Life Assurance

JOB SUMMARY

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.

The role holder will need to be vaccinated against anthrax to allow them to perform their duties where required within areas where anthrax vaccine is manufactured and tested.

The above is only an outline of the tasks, responsibilities and outcomes required of the role.  You will carry out any other duties as may reasonably be required by the manager.

Personal Specification