Job Description
Job Title: Cleanroom Technician - Level 1
Location: Leatherhead, Surrey
Salary: Competitive
Job Type: Full Time, Permanent
About Us:
MatOrtho is an internationally recognised joint replacement devices innovator dedicated to improving the quality of life of all patients through technical innovation and ethical design.
About The Role:
The purpose of the role will be to maintain a controlled environment in the cleanroom, process components and instruments, pack, label and ship orthopaedic products in compliance with regulatory rules and guidelines. Execute basic environmental monitoring (EM) activities and routine cleaning within cleanroom to support cGMP and ISO 13485 compliance, including sampling, data recording while adhering to site EM procedures.
Duties & Responsibilities:
Working in accordance with cGMP practices and guidelines to:
* Work in an ISO Class 7 cleanroom to manufacture products for terminal sterilisation
* Maintain a controlled environment in the cleanroom, working in accordance with cleanroom procedures including, but not limited to, full body gowning and perform daily cleaning to set standards
* Complete cleanroom processes to ensure work is cleared before the end of the day
* Receive and inspect incoming materials according to specifications, while checking for contamination and quality compliance
* Clean, assemble and package orthopaedic products according to set standards
* Operate equipment and machinery required in the assembly of orthopaedic products
* Communicate status of operations to Cleanroom Manager through weekly meetings to report process and or safety issues
* Ensure training modules and refreshers are completed within set deadlines
* Report defective materials and/or that of questionable condition according to the Standard Operating Procedure
* Be a reliable member of the cleanroom production team
* Prepare the cleanroom (materials, equipment, packaging etc) to eliminate errors in accordance with Good Manufacturing Practices
* Work closely with Cleanroom Manager to ensure deadlines are met in addition to completing daily tasks required outside of production (including but not limited to validation, maintenance, environmental monitoring, bioburden testing and quality assignments)
* Perform final quality checks of finished product according to standard procedures
* Collaborate with Quality Assurance to identify, implement and support continuous improvement of cleanroom processes and procedures
* Print implant labels and pack components, ensure products are ready for checks and shrink-wrapping
* Pack and ship batches for terminal sterilisation, ensure batches are ready for dispatch in within set deadlines
About You:
Personal attributes/competencies:
* Strong attention to detail, able to focus on accuracy and quality
* Able to work with precision, manually handling small parts, requiring good eyesight and hand/eye coordination
* Able to take initiative
* Able to work independently without being prompted
* Able to prioritise and plan work activities, manage time efficiently and adapt to changing priorities
* Ability to work within tight timelines to meet deadlines
* Must be able to follow detailed instructions
* Able to effectively communicate with others
* Strong team ethics, Work efficiently with cleanroom colleagues
* Able and willing to learn and develop new skills
* Good personal hygiene. Expect regular full body gowning and repeated surgical hand washing
* Must be able to meet the physical requirement of lifting and carrying loads, operating mechanical presses and cleaning
Skills and experience:
Essential:
* Strong literacy and numeracy abilities
* Basic computer skills (Microsoft Word and Excel)
Desirable:
Full training will be provided but experience in the following would be welcome:
* Working in a controlled environment
* Working within a GMP environment
* Undertaking stock counts
* UK Driver's License
Education and qualifications:
Essential:
* Good standard of education with GCSE or equivalent Maths and English.
Benefits:
* Contributory Group Personal Pension scheme (Aviva)
* Salary exchange scheme
* Group Life Assurance
* Group Income Protection
* Private healthcare
* Health Cash Plan
* Discounted Gym Membership
* Discounts and rewards scheme
* Cycle-to-work Scheme
* Interest-free rail or bus season ticket loan
* Employee Assistance Programme (24/7 helpline)
* 25 days' annual leave, plus UK statutory bank holidays
* Second Medical Opinion Scheme
* myStrength mental health resource
* Free parking (subject at the discretion of business park owners)
* Reimbursement of professional membership fees
* Staff Referral Programme
* Access to financial planning advice
* Company Social Events
Please Note:
We will not be accepting applications from agencies for this vacancy
Please click the APPLY button to send your CV and Cover Letter for this role
Candidates with experience or relevant job titles of; Cleanroom Technicians, Laboratory Technicians, Sterile Environment Specialist, Cleanroom Operative, Controlled Environment Technicians, Sterile Room Operator, Manufacturing Technician, Manufacturing Operator, Packing Operative may also be considered for this role.
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