Address
Form of work
SalaryIntroduction to role
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.
PBL offer 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
The Process Engineer is responsible for providing specialist technical engineering expertise in some or all of the equipment and systems used by PBL in the manufacture of pharmaceutical products. Examples include fermenters & process vessels, autoclaves and clean utilities.
They will take a lead role in for coordinating the response of the Engineering department to equipment failure and to the delivery of reactive remedial works, including the clear communication of issues and status to stakeholders at all levels of the organisation.
This role will require them to work routinely within the PBL Quality System to ensure that process equipment and utility systems within the GMP envelope remain compliant with current Good Manufacturing Practice, for example by investigating and determining the root cause of failures and ensuring change, especially to equipment, is managed and controlled.
They will additionally be responsible for the identification and delivery of small process improvement initiatives/projects relating to equipment and systems and will support the PBL capital plan by assisting in the delivery and bringing into use of new equipment, facilities, and utilities.
Key Responsibilities
- To act as a technical Subject Matter Expert for equipment and systems used in the manufacture of pharmaceutical products. This includes providing practical or technical training in applicable Engineering SOPs and associated documents to PBL staff both inside and outside of the engineering group
- To lead the troubleshooting of faults with equipment and systems used within manufacturing. This involves establishing and addressing root causes, providing practical solutions to identified problems and maintaining compliance with the requirements of cGMP
- To liaise with maintenance teams and other engineering personnel responsible for equipment servicing, calibration and reliability whilst helping to ensure a safe system of work is followed.
- To maintain appropriate communication of information relating to Engineering activities with stakeholders in manufacturing, quality and engineering.
- To perform failure investigation and root cause analysis determination of deviations through the PBL non conformance system.
- To monitor the performance of equipment and systems supporting manufacturing, identifying opportunities for process improvement
- To project manage the implementation of process improvements and/or CAPA actions through the delivery of small projects, managed through the PBL change management process
- To generate, review and approve technical engineering documentation including specifications, protocols, reports, engineering Standard Operating Procedures (SOPs) and technical drawings
- To represent Engineering as project engineer/ technical specialist on process related capital projects. This will include providing input into equipment design and selection and participating in the testing and qualification of new equipment and systems.
With the support of the Process Engineering Manager and the Director of Engineering to represent the Engineering function at MHRA and FDA audits as a subject matter expert for Process Engineering
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.
The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organization
Personal Specification
Qualifications
Essential: Bachelors or Masters Degree in an applicable engineering discipline or an equivalent qualification along with a level of experience or engineering apprenticeship
Desirable: holds Chartered Engineering Status
Knowledge / Experience
Essential: can demonstrate practical experience of the operation, commissioning, trouble shooting and/or validation of equipment.
Broad technical knowledge, good grasp of underlying engineering principles and regulatory framework.
Experience of working within GMP Quality System, particularly QRM (quality risk management), change management, non-conformance management and CAPA (corrective and preventative actions), agreeing programmes and reporting progress for internal customers.
Desirable: Knowledge of Biopharmaceutical GMP Manufacturing processes, experience as a technical SME during regulatory inspections and internal audits
Specific Requirements: Systematic, trouble shooting skills, accurate and clear record keeping, capability to create engineering reports, good level of numeracy and computer skills.
You must be a British National and be able to pass security clearance to be considered for this role
