Associate Technician, Solutions Manufacturing

JenaValve is a privately owned medical device company focused on the design and manufacture of Pericardial Transcatheter Aortic Valve Replacement (TAVR) Systems, intended to treat patients with Symptomatic, Severe Aortic Regurgitation and Stenosis.

Our production site in Leeds, manufactures the proprietary porcine pericardial heart valve used in the JenaValve Pericardial TAVR System.

We are looking to recruit a Solutions Technician to join our production support team in Leeds.

The Solutions Technician will be responsible for providing support services for the manufacturing process in the Leeds clean room environments whilst working in line with the Quality Management System (QMS).

• Manufacture all Solutions to be used in the Leeds production facility for the valve manufacturing process per approved work instructions.
• Ensure correct manufacture, testing, storage, handling, issue, cleaning and disposition of all products, components, equipment, instruments and solutions per approved work instructions and procedures.
• Complete production records and other documents in line with good documentation practices (GDP) and internal procedures.
• Ensure that activities are conducted according to the assigned priorities to support production; directly and indirectly.
• Support the process and controls for all inventories and raw material supplies.
• Perform checks of own work and others against specifications and defined failure modes.
• Complete all operations in accordance with work instructions, good manufacturing practices, good documenting practices in compliance with the JenaValve quality system, including recording traceable information in DHRs·      
• Support all manufacturing-related aspects of a project within a team as required.
• Support activities corresponding to other work procedures, as requested, to provide support to any operations processes.
• Be aware of Health and Safety information for the applicable processes utilized in the organization.
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others.

• GCSE or equivalent.
• Some experience of manufacturing, GMP, clean room, medical device desirable.

• Ability to utilise scale balances, pH meter, and other chemistry related equipment.
• Must have ability to perform detailed tasks accurately.
• Ability to perform basic mathematic operations.
• Must be able to work effectively and collaborate within cross functional teams.
• Ability to read, comprehend and speak English, and good communication skills required.
• Knowledge of and adherence to Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
• Successful completion of required training and demonstrated competency on assigned manufacturing processes.
• Adhere to all rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
• Basic computer skills.

• Ability to perform highly detailed chemical solutions preparation while standing for extended periods during the work shift.
• Ability to perform work requiring close visual acuity.
• Ability to work in a controlled and non-controlled environment while wearing full cleanroom gowning including gowns, gloves, mask, hairnet, boot covers, and other PPE as needed.
• Ability to follow strict safety, contamination control, and cleanroom protocols.
• Must be able to stand, walk, and sit for prolonged periods of time.

Pay:

£27,360 per year

Benefits:

• Casual dress
• Company pension
• Free parking
• Health & wellbeing programme
• Private medical insurance
• Employee referral scheme
• Sick pay