Contingent Worker - Mfg Process Technician

Orthofix; Irvine; On-site; GBP 26,000 - 34,000; Full time

Job summary

Orthofix is seeking a Production/Process Technician in Irvine to support build plans, packaging, and ERP transactions in a GMP environment.

The role emphasizes adherence to SOPs, precision in documentation, and teamwork to ensure on-time production. Candidates should have a high school diploma and be willing to work overtime as needed.

Qualifications

• Experience in an FDA-regulated manufacturing environment, preferably in a Medical Device manufacturing environment.
• Mathematical skills
• Knowledge of Good Manufacturing Practices (GMP)
• Punctual and reliable attendance
• Team-oriented and willing to learn multiple manufacturing roles
• Ability to read/write English and maintain accurate documentation

Responsibilities

• Supports formulation build of products.
• Supports preparation and verification of components.
• Follows SOP requirements for cleaning, labeling, and sealing of processed units.
• Supports ERP move and material transactions are completed timely.
• Follow Company policies and procedures compliance.
• Transfer and stock supplies for controlled areas (autoclave, clean room, quality areas).
• Assist with final packaging activities (kitting, prepping lots).
• Assist main clean room activities as required.
• Organize gowning supplies from approved vendors and stock in Gowning Room.
• Assist in waste water treatment for proper disposal.
• Perform daily general cleaning and other duties as assigned.
• Perform other job duties as assigned.

Skills

GMP knowledge

FDA-regulated environment

Multi-tasking

Attention to detail

Education

High School Diploma

Tools

Oracle ERP

Job description

Guided by our organizational values - Take Ownership | Innovate Boldly | Win Together - we collaborate closely with world-class surgeons and other partners to improve people's quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the partner in Med Tech.

Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people's lives? Look no further.

JOB PURPOSE

The technician is responsible for prepping and packaging of supplies to support the build plan and forecast demands. Assisting Manufacturing Supervisor / Manager in overseeing production team to ensure all production operations are in compliance with SOP's, current GMPs, QSR, GTP, and ISO standards as well as company procedures.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Supports formulation build of products.
• Supports preparation and verification of components.
• Follows SOP requirements for cleaning, labeling, and sealing of processed units.
• Supports ERP move and material transactions are completed timely.
• Follow Company policies and procedures compliance.
• Properly transfer and stock supplies for all controlled areas ( autoclave, clean room and quality areas)- complete system transactions where applicable (for inventory control purposes)
• Supports ERP move and material transactions are completed timely.
• Assist with final packaging activities, such as but not limited to, kitting and prepping lots.
• Assist in main clean room activities, as required
• Assist in organizing delivered gowning supplies from approved vendor and stocking of gowning supplies in the Gowning Room.
• Assist in performing waste water treatment for proper disposal.
• Assist with daily general cleaning and performs other job duties as assigned.
• Perform other job duties as assigned

MINIMUM QUALIFICATIONS

Education/Certifications:

• High School Diploma or equivalent required

Experience, Skills, Knowledge and/or Abilities:

• Experience in an FDA-regulated manufacturing environment, preferably in a Medical Device manufacturing environment
• Mathematical skills
• Knowledge of Good Manufacturing Practices (GMP)
• 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
• Must have the ability to multi-task in a fast-paced environment
• 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:

• Knowledge of Lean Manufacturing and Six Sigma Green or Black Belt
• Knowledge of Quality System Regulation (QSR) and International Organization for Standardization (ISO)

Additional Experience, Skills, Knowledge and/or Abilities:

• Medical device manufacturing/assembly/packaging experience
• 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 standing.
• This position may require some bending, stooping, kneeling, or crouching.
• This position may require some walking.
• This position requires frequent or continuous 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.

Contingent Worker - MFG Process Technician Irvine