Production Technician Autoclave Specialist

4 weeks ago

Irvine, North Ayrshire, United Kingdom Orthofix Full time
Why Orthofix?

We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial, and manufacturing footprint.

Come be part of our global team of dedicated professionals who demonstrate every day their commitment to our mission of improving the lives of patients. At Orthofix, our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean, and Have Fun.

How You'll Make a Difference

The Production Technician-Autoclave is responsible for completing manufacturing assignments as directed by the Manufacturing Manager and/or the Production Supervisor. Typical duties and tasks must be completed in compliance with the requirements of Standard Operating Procedures (SOP) per current GMP's, QSR, and company policies, laws, and procedures.

Key Responsibilities
  1. Maintain the disinfection (steam autoclave) process to support manufacturing activities.
  2. Wash and/or wrap equipment and supplies.
  3. Loading and unloading of drying oven and steam disinfection equipment.
  4. Place purchase requisitions for production spare parts and tooling, as necessary.
  5. Verify cycle printouts and logbooks.
  6. Properly transfer and stock supplies for all controlled areas (autoclave, clean room, and quality areas) - complete system transactions where applicable (for inventory control purposes).
  7. Assist with final packaging activities, such as but not limited to, kitting and prepping lots.
  8. Assist in main clean room activities, as required.
  9. Assist in organizing delivered gowning supplies from approved vendors and stocking of gowning supplies in the Gowning Room.
  10. Assist in performing waste water treatment for proper disposal.
  11. Compliant with company policies and procedures.
  12. Assist with daily general cleaning and performs other job duties as assigned.
Requirements

Education/Certifications:

  • High School Diploma or equivalent required.

Experience, Skills, Knowledge, and/or Abilities:

  • 0-2 years of experience in an FDA-regulated manufacturing/controlled environment, preferably in a Medical Device Experience or human-tissue assembly/production.
  • Must be able to speak, write, and read English with excellent understanding.
  • Ability to adapt to a fast-paced environment.
  • Individual must be punctual and have reliable attendance.
  • Individual must be cooperative and willing to work in a team environment.
  • Must be able to follow direction provided by authorized supervision.
  • Knowledge of Good Manufacturing Practices (GMP).
  • Ability to perform repetitive tasks consistently and proficiently.
  • Must be able to interact with peers, Manufacturing Supervisor/Manager.
  • Must be proficient in tasks performed (after suitable training period) and have attention to detail.
  • Ability to work overtime, including evenings, weekends, and holidays.
  • Ability to utilize a computer, telephone, label printer, and copy machine as well as other general office equipment.
Preferred Qualifications

Education/Certifications:

  • No additional requirements.

Additional Experience, Skills, Knowledge, and/or Abilities:

  • Knowledge of Quality System Regulation (QSR) and International Organization for Standardization (ISO).
  • Experience working in a controlled environment (preferably ISO class 5, 7 & 8 or better).
  • Oracle ERP experience.
Physical Requirements/Adverse Working Conditions
  • This position may require some frequent or continuous standing.
  • This position may require some frequent or continuous bending, stooping, kneeling, or crouching.
  • This position may require some frequent or continuous walking.
  • This position may require some frequent or continuous moderate lifting of 15-40lbs.
  • This position may require some frequent or continuous pushing and/or pulling.
  • This position may require some repetitive motion involving substantial movements of the wrist, hands, and/or fingers; or grasping with hands and/or fingers.
  • This position may require some frequent or continuous exposure to dust, fumes, gases, odors, or other airborne irritants.
  • This position may require some frequent or continuous exposure to chemicals and/or solvents.

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