A leading medical device manufacturer requires an experienced Protein Purification Technician to join its team. You will be supporting a therapeutics manufacturing facility and will be involved in involved in continuous improvement activities and personnel development of junior team members. To be considered you must have previous experience in protein purification and cell culture within a manufacturing environment.
To support the manufacture of all products within the Therapeutics Manufacturing Facility (TMF) in an efficient and safe manner to the required standards to assist with planning and organisation to meet the demands of the Production schedule 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 TMF and to be involved in continuous improvement activities and personnel development. Reports to the Manufacturing Supervisor.
May include some or all of the following:
- To develop an in depth and comprehensive understanding of the products and processes within the TMF demonstrating expert competency in Buffers and trained competency Modification Enzymes Finished Product Trichomonas Cell Culture and Antibody Purification (if applicable) and other products as required
- To assist when required in the organisation prioritisation co-ordination planning and supervision of manufacturing activities within the TMF 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 TMF including materials management (including batch packing and Kanban management for consumables) and facility maintenance (including equipment and facility logs and checks) as required under ISO9001 and cGMP guidelines
- To assist with maintaining the TMF 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 TMF under guidance and supervision where necessary
- To demonstrate trained competency in the completion of TMF 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 TMF 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 Manufacturing Supervisor.
- To have a good an understanding of TMF equipment control change and investment (small capitals) and TMF 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
- Good understanding of Protein Purification Techniques
- Good cell culture technique is advantageous
- Experience of working in Clean Room environments
- Experience in supervising and coaching is advantageous
- Experience in Batch Review.
Skills / Pre-requisites:
- Required to work efficiently and independently a majority of the time.
- Must have the ability to plan and prioritize varying and high volumes of work.
- To work well under pressure in a constantly changing environment.
- Have good attention to detail.
- Develop the skill and flexibility to operate appropriate equipment and utilities across a wide range of activities associated with production in an effective and efficient manner.
- Be able to liaise well with other team members and with other departments as required to co-ordinate tasks and activities.
- Good computer skills.
- Enjoy new opportunities and challenges.
Salary £25k - £35k
Job Ref: 6260