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Production Technician Autoclave Specialist

2 months 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.

Our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean, and Have Fun. We are committed to improving the lives of patients through our mission.

Job Summary

The Production Technician-Autoclave is responsible for completing manufacturing assignments as directed by the Manufacturing Manager and/or the Production Supervisor. This role requires attention to detail, ability to follow direction, and a commitment to quality.

Key Responsibilities
  • Maintain the disinfection process to support manufacturing activities.
  • Wash and/or wrap equipment and supplies.
  • Loading and unloading of drying oven and steam disinfection equipment.
  • Place purchase requisitions for production spare parts and tooling, as necessary.
  • Verify cycle printouts and logbooks.
  • Properly transfer and stock supplies for all controlled areas (autoclave, clean room, and quality areas).
  • Assist with final packaging activities, such as kitting and prepping lots.
  • Assist in main clean room activities, as required.
  • Assist in organizing delivered gowning supplies from approved vendors and stocking of gowning supplies in the Gowning Room.
  • Assist in performing waste water treatment for proper disposal.
  • Compliant with company policies and procedures.
  • Assist with daily general cleaning and perform other job duties as assigned.
Requirements
  • High School Diploma or equivalent required.
  • 0-2 years of experience in an FDA-regulated manufacturing/controlled environment, preferably in a Medical Device Experience or human-tissue assembly/production.
  • Ability 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
  • 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.