Cleanroom Technician - Level 1

Job Title:

Cleanroom Technician - Level 1

Location:

Leatherhead, Surrey

Salary:
Competitive

Job Type: Full Time, Permanent

About Us:

Mat Ortho® 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…