Process Technician - 254446

Medix™

Irvine (CA)

On-site

USD 38,000 - 60,000

Full time

4 days ago
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Job summary

Medix is seeking a Process Technician to support production activities on 1st and 2nd shifts. The role involves hands-on formulation, cleanroom tasks, and strict adherence to GMP and FDA requirements. Strong computer skills and excellent English communication are essential.

Candidates should have a high school diploma and 0–2 years in an FDA-regulated environment; medical device experience is a plus. Willingness to work overtime as production demands may require evenings, weekends, or holidays.

Qualifications

  • Must have a High School Diploma or equivalent.
  • 0-2 years in an FDA-regulated environment; medical device or human-tissue assembly a plus.
  • Solid understanding of GMP and strong computer proficiency.
  • Excellent written and spoken English communication.

Responsibilities

  • Provide hands-on production support for formulation, component prep, cleanroom activities, and final kitting/packaging.
  • Perform ERP inventory transactions for controlled areas, cleanrooms, and supplies to keep material moving.
  • Follow SOPs for cleaning, labeling, sealing units, manage gowning inventory and stock in controlled areas.
  • Assist with quality and compliance ensuring adherence to FDA regulations, GMP, and company guidelines.

Skills

GMP knowledge
Computer proficiency
English communication

Education

High School Diploma

Tools

ERP system

Job description

Process Technician (Hiring for 1st and 2nd shift):
What You'll Be Doing Day-to-Day:
  • Production Support: Hands-on assistance with product formulation, component preparation, cleanroom activities, and final kitting/packaging.
  • Operations & ERP: Keeping material moving smoothly by completing accurate ERP inventory transactions for controlled areas, cleanrooms, and supplies.
  • Cleanroom & Facility Care: Following SOPs for cleaning, labeling, and sealing units, maintaining gowning inventory, managing controlled area stock, and supporting daily facility upkeep (including wastewater treatment disposal).
  • Quality & Compliance: Ensuring strict adherence to FDA regulations, Good Manufacturing Practices (GMP), and company guidelines at every step.
What We're Looking For:
  • Education & Experience: High School Diploma (or equivalent). 0-2 years of experience in an FDA-regulated environment- medical device or human-tissue assembly experience is a huge plus!
  • Core Skills: Solid understanding of GMP, strong computer proficiency, and excellent English communication (written and spoken).
  • Work Style: Punctual, adaptable to a fast-paced setting, highly detail-oriented, and a great team player who follows instructions well.
  • Availability: Willingness to work overtime, including evenings, weekends, or holidays as production demands.
Physical Demands:
  • Comfortable with frequent bending, stooping, kneeling, and repetitive hand/wrist movements.
  • Ability to routinely lift and move materials weighing between 15-40 lbs.
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