A leading medical device manufacturer requires a Biochemistry Technician to join its team. You will be supporting a therapeutics manufacturing facility and carry out a range of technical and administrative duties to support the day-to-day running of the lab. To be considered, you will ideally be educated to degree level in a bio-science and have some previous lab experience.
May include some or all of the following:
- To develop a basic understanding of the products and processes within the TMF, demonstrating trained competency in Buffers and unsupervised competency across 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,
- 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 actively assist, supervised, in the completion of TMF CAPAs, document updates, deviations and reports, as required.
- To support 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.
- 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.
Education / Experience:
- Educated as a minimum degree level in a bio-science
- Good understanding of ISO9001 and cGMP is preferable,
- Understanding of Protein Purification and Cell Culture techniques are advantageous
- Experience of working in Clean Room environments is advantageous
Skills / Pre-requisites:
- Required to work efficiently and independently with supervision some 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 advantageous.
Salary £20k - £30k 12 month Fixed Term Contract
Job Ref: 6261