A global diagnostics business has an exciting opportunity for a Process Technician to join its team. You will divide your time between routine fermentation, downstream purification and chromatography as well as supporting other areas of manufacturing and facility upkeeping. You will be educated to degree level in a relevant subject with proven experience of fermentation or downstream purification techniques. You must have experience working to GMP standards.
You will divide their time between routine fermentation, downstream purification and chromatography as well as supporting other areas of manufacturing and facility upkeeping. Weighting of these roles will be dependent on the manufacturing plan and workload assigned accordingly through two-way discussion with the line manager. Plays an important role in the shift team meeting the manufacturing plan in compliance with quality and HS&E. Expectation to support some departmental initiatives, management and activities across the business. Reports to the shift Process Supervisor.
May include some or all of the following:
- To support the manufacture of all products within the cGMP Facility in an efficient and safe manner to the required standards.
- To develop an in depth and comprehensive understanding of the products and processes within the department, demonstrating expert competency in either fermentation or downstream purification or chromatography and to ensure that operations and documentation are completed to comply with ISO9001 and relevant cGMP regulations at all times.
- To carry out a range of technical and administrative duties to support the day-to-day running of the production and to be involved in continuous improvement activities and personnel development.
- To assist when required in the organisation, prioritisation, co-ordination, planning and supervision of manufacturing activities within the department to ensure efficient use of resources to meet manufacturing plans.
- To ensure that safe working methods and practices are adopted at all times and in accordance with Company policy for both the safety of the post holder and others in the working environment,
- To ensure that manufacturing activities are carried out as per instruction and procedures with accurate, complete and detailed records (in compliance with ISO9001 and cGMP regulations) to ensure all aspects of manufacture are readily traceable, and be trained in Production documentation review,
- To demonstrate expert competency in general operations within the production department, including materials including equipment and facility logs and checks), as required under ISO9001 and cGMP guidelines,
To assist with maintaining the facilities to a high standard of hygiene and cleanliness, demonstrating expert competency in routine cleaning of equipment and production areas and 5S audits as well as responsibility for general housekeeping and tidiness,
- To communicate at the earliest opportunity any events, actions or deviations which may impact safety, product quality or compliance, including identification of maintenance and breakdown issues, raising EWRs where necessary,
- To be familiar with, and use, all appropriate administrative systems (including planning, training and competency) and documentation applicable to the department, under guidance and supervision where necessary,
- To demonstrate trained competency in the completion of CAPAs, document updates, deviations and reports, as required.
- To have active, unsupervised involvement in continuous improvement activities and departmental project work across all aspects of manufacturing as and when required.
- To attend meetings, both internal and external, as required, representing the Department / Company in a professional manner, with an expectation to take on additional roles required for the department e.g. safety officer, first aider, forklift driver.
- To provide, as dictated by the needs of the business, an operations resource in other areas of work in and outside of the department in order to maximize the site flexibility, optimize efficiency and drive continuous improvement.
- To support the development of junior technicians through carrying out specified coaching requests, supervision and providing developmental feedback to the Process Supervisor.
- To have a good an understanding of equipment control, change and investment (small capitals) and utilities and related procedures, with occasional involvement in aspects of their validation,
Education / Experience:
- BSc in Biology, Chemistry or other related discipline is preferable,
- Good understanding of ISO9001 and cGMP,
- Experience of fermentation or downstream purification techniques,
- Experience of working in Clean Room environments,
- Experience in supervising and coaching is advantageous,
- Experience in Batch Review.
Salary £30k - £40k
Job Ref: 6931