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Demineralization Technician I

3 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, and this is just the beginning

Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and 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

JOB PURPOSE

The technician is responsible for the demineralization process and assists in completing the build plan and forecast demands. Responsible for critical equipment (used for demineralization) and promotes a team environment. The technician is responsible for ensuring all demineralization operations comply with SOP's, current GMPs, QSR, GTP, and ISO standards as well as company procedures.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Follow company policies and compliance procedures. Support preparation and verification of components, tools, and equipment. Support formulation build of products. Follow SOP requirements for cleaning, labeling of processed items and equipment teardowns after processing is completed. Assist in organizing delivered gowning supplies from approved vendor and stocking of gowning supplies in the Gowning Room. Support the demineralization process & activities as scheduled by the Line Lead and Supervisor. Prepare and weigh out NDBM/NDBF per the work instruction. Setup and assemble demineralization vessels, tools, equipment, and workstations. Prepare water and acid for NDBM/NDBF. Perform visual check of HCL, buffer, and RO/DI Water for each station prior to start of process as well as during the process, to ensure chemical levels are to specifications. Setup the Laminar Airflow stations for post demineralization activities. Transfer demineralized DBM to trays, label, and load trays into freezer. Support ERP move and complete material transactions. Assist with review of manufacturing related documentation. Monitor HCL, buffer, NDBM/NDBF inventory and submit Kanban cards when appropriate. Assist with general daily cleaning, restocking supplies, daily environmental/equipment monitoring in Demin area and cleanroom. Perform system transactions where applicable. Assist in main clean room activities as required and perform other duties as assigned.

MINIMUM QUALIFICATIONS

Education/Certifications:

High School Diploma or equivalent required

Experience, Skills, Knowledge and/or Abilities:

0-1 of experience in an FDA regulated manufacturing environment Individual must be punctual and have reliable attendance Strong mathematical skills Knowledge of Good Manufacturing Practices (GMP), Quality System Regulation (QSR) and International Organization for Standardization (ISO) Individual must be cooperative and willing to work in a team environment Must be able to follow direction provided by authorized supervision Demonstrates ability to adapt to fast-paced, team-oriented work environment Ability to analyze, troubleshoots, and resolves problems/issues as they arise Must be willing to learn different jobs in the manufacturing environment Must be able to perform repetitive task(s) consistently and proficiently Must be able to speak and read English with excellent understanding Must be able to keep legible and correct documentation of activities Must be proficient in tasks performed (after suitable training period) and have attention to detail Ability to utilize a computer, telephone, label printer and copy machines as well as other general office equipment. Ability to work overtime, including evenings, weekends, and holidays

PREFERRED QUALIFICATIONS

Education/Certifications:

Associate Degree in a technical or science discipline preferred. Basic understanding of Lean Manufacturing and Continuous Improvement

Additional Experience, Skills, Knowledge and/or Abilities:

Uphold teamwork, excellent communication and interpersonal skills Experience working in a controlled environment (preferably ISO class 5, 7 & 8 or better) Experience in a Medical Device manufacturing environment Oracle ERP experience Agile Product Lifecycle management software

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

This position may require some standing. This position may require some bending, stooping, kneeling, or crouching. This position may require some walking. This position requires frequent or moderate lifting of 15-40lbs. This position requires frequent or continuous pushing and/or pulling. This position requires frequent or continuous repetitive motion involving substantial movements of the wrist, hands and/or fingers; or grasping with hands and/or fingers. This position may require some exposure to dust, fumes, gases, odors, or other airborne irritants. This position requires frequent or continuous exposure to chemicals and/or solvents.

The anticipated base hourly rate for an employee who is located in California for this position is $ to $ per hour, plus bonus and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc. The Company is a multi-state employer and this pay scale may not reflect the pay scale for an employee who works in other states or locations.

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