Manufacturing Technician

Manufacturing Technician

The Manufacturing Technician is responsible for the production of pharmaceutical assemblies within a Good Manufacturing Practice (GMP) environment. This role involves various tasks including the preparation of solutions and production materials within the Formulation Department. With openings on both the first and second shifts, the technician will engage in fabrication, in-process testing, and packaging, all while ensuring compliance with GMP standards.

Responsibilities

• Perform setup, verification, and teardown of equipment before and after processing.
• Prepare solutions and production materials in the Formulation Department.
• Execute manufacturing tasks such as fabrication, in-process testing, and packaging.
• Document production activities in manufacturing lot history records.
• Clean production equipment and areas to maintain GMP standards.
• Utilize pipettes and micro weights for precise measurements.
• Conduct analysis of data as needed.
• Formulate polymers and spray coating formulations.
• Set up coating machines and inspect balloon catheters.
• Prepare excipient formulations and spray coating formulations.
• Support the preparation, mixing, inspection, filtration, and documentation of solutions for drug-loaded polymer microspheres.
• Operate mixers, jacketed tanks, TCUs, peristaltic pumps, ultrasonic baths, and other equipment.
• Conduct in-process inspections and maintain environmental controls.
• Follow line clearance, cleaning, PPE, and safety requirements.
• Escalate deviations or out-of-spec results to supervision or engineering.
• Operate machinery to produce medical devices meeting specifications.
• Follow manufacturing instructions and update relevant job documentation accurately.
• Perform product packing and sterilization preparation.
• Inspect products using microscopes.
• Troubleshoot product and process-related issues.
• Work with toxic chemicals and powders in a lab environment.
• Handle delicate medical device components with precision and care.
• Conduct visual inspections using microscopes or magnification tools to verify product quality.
• Complete all required production and quality records accurately.
• Maintain cleanliness of workstations, tools, and surrounding areas according to 5S and GMP requirements.
• Communicate issues such as equipment malfunctions or material shortages promptly to the Line Lead or Supervisor.
• Participate in basic problem-solving and continuous improvement activities.

Essential Skills

• 2 years of experience working with chemicals for positions in the Formulation Department.
• 2 years of medical device or pharmaceutical manufacturing experience for positions in the Formulation Department.
• 1 year of related experience in pharmaceutical or medical device manufacturing for positions in the Vialing Department.
• Proficiency in GMP, aseptic techniques, SOP adherence, packaging, and sanitization.

Additional Skills & Qualifications

• Minimum High School Diploma or GED.
• Basic math skills and comfort with working with toxic chemicals.
• Experience operating laboratory and manufacturing equipment.

Why Work Here?

Join a company that is at the forefront of revolutionizing healthcare through innovative drug device combination products. Our work environment is collaborative and focused on addressing critical medical needs. With global offices, we offer opportunities for growth and the chance to be part of a mission-driven team dedicated to making a difference in the treatment of coronary and peripheral artery disease.

Work Environment

The role operates in a cleanroom/manufacturing setting. The first shift is from 2:30 am to 11 am, and the second shift is from 11 am to 7:30 pm, with some Saturdays as needed. The work involves handling toxic chemicals, adhering to detailed work instructions, and maintaining strict cleanliness and safety standards.

Job Type & Location

This is a Contract to Hire position based out of Irvine, CA.

Pay and Benefits

The pay range for this position is $24.20 - $26.40/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine, CA.

Application Deadline

This position is anticipated to close on Jul 13, 2026.