Production Operator
7 months ago
**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
- Onsite canteen
- Life Assurance
This post is part of the team responsible for the fermentation, extraction and downstream processing of Erwinase. 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. 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). Shift working, working a 24-hour, 5-day rota (with a night shift allowance), is required for the part of the year when fermentation and recovery processes performed at FPP are in progress.
**Key Responsibilities**:
- Carry out duties involved in the manufacture of Erwinase, 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
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**:
**Essential**
**Desirable**
**Eligibility**
- Current, valid Right to Work in UK
- A good standard of written and spoken English
**Equality and Diversity**
- An understanding of and commitment to equality of opportunity and good working relationships, both in terms of day-to-day working practices, but also in relation to management systems
**Qualifications**
- GCSE Mathematics, English and Science
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**Kn**
**o**
**w**
**ledge and Experience**
Experience as defined by type/level (not length)
- Experience of working in a manufacturing environment, cleanroom or related industry
- Experience of working to deadlines or schedules
- Experience of following written procedures
- Experience of keeping clear and acc
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