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GMP Manufacturing Technician

Medical Devices

Kent £25k – £35k
permanent Job Ref: 6540

Description

  • A leading diagnostics business requires a Manufacturing Technician to join its team. Your role will be to support the manufacture of all products within the Therapeutics Manufacturing Facility which will include a range of both technical and administrative duties. You will be degree educated in a life science subject or have the equivalent lab experience.  An understanding and ideally experience of protein purification and cell culture is required. Previous experience must have been in another GMP facility. 


    Responsibilities:

    May include some or all of the following:

    • To develop a good understanding of the products and processes within the TMF demonstrating trained competency in Buffers Modification Enzymes Finished Product Trichomonas Cell Culture and Antibody Purification (if applicable) and other products as required
    • 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 able to assist with Production documentation review unsupervised
    • To demonstrate trained 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 trained 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 unsupervised competency in the completion of TMF CAPAs document updates deviations and reports as required
    • To have active involvement under supervision 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 some 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 lead by example and assist in the training of junior technicians under direction and as required
    • To develop 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 is preferable
    • Understanding of Protein Purification Techniques is preferable
    • Cell culture technique is advantageous
    • Experience of working in Clean Room environments is preferable

    Skills / Pre-requisites:

    • Required to work efficiently and independently with minimal supervision most of the time.
    • Must have the ability to plan and prioritize assigned tasks and project work.
    • 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.

    Training:

    •  Additional training will be provided as required and agreed with TMF Manager

Salary £25k - £35k

Job Ref: 6540