Manufacturing Technician

Manufacturing Technician

This role is responsible for manufacturing pharmaceutical assemblies in a GMP-regulated environment, with a focus on solution preparation and production materials within the Formulation Department. You will perform a variety of hands-on manufacturing tasks, including formulation, in-process testing, packaging, and documentation, while adhering to strict quality, safety, and cleanliness standards.

Responsibilities

• Perform setup, verification, and teardown of manufacturing equipment before and after processing to ensure accurate and efficient production.
• Prepare solutions and production materials, including weighing, mixing, heating, cooling, sampling, and filtration activities.
• Execute manufacturing tasks such as fabrication, in-process testing, and packaging of pharmaceutical assemblies and medical devices.
• Document all production activities accurately in manufacturing lot history records and controlled documentation to maintain full traceability.
• Clean and maintain production equipment and production areas to meet GMP and cleanroom standards.
• Utilize pipettes, micro balances, and other laboratory tools to handle materials and perform precise measurements.
• Perform data analysis as needed to support process understanding and continuous improvement.
• Formulate polymers and spray coating formulations according to established procedures.
• Set up coating machines and perform coating, inspection, and folding of balloon catheters.
• Prepare excipient formulations and spray coating formulations to support product manufacturing.
• Support the preparation, mixing, inspection, filtration, and documentation of solutions used in the production of drug-loaded polymer microspheres.
• Operate mixers, jacketed tanks, temperature control units (TCU), peristaltic pumps, ultrasonic baths, bottle rollers, and balances.
• Perform in-process inspections and environmental controls to verify product and process compliance.
• Follow line clearance, cleaning, personal protective equipment (PPE), and safety requirements at all times.
• Escalate deviations, out-of-specification results, or unusual observations to supervision or engineering promptly.
• Operate machinery to produce medical devices according to defined specifications and manufacturing instructions.
• Follow manufacturing instructions and update job documentation accurately to ensure complete traceability.
• Support product packing and preparation for sterilization according to established procedures.
• Perform product inspection using microscopes to verify product quality and identify defects.
• Troubleshoot product and process-related issues in collaboration with supervision or engineering.
• Work safely with toxic chemicals and powders in a laboratory and cleanroom environment.
• Adhere to GMP, aseptic techniques, standard operating procedures (SOPs), packaging, and sanitization requirements.

Essential Skills

• Minimum of a high school diploma or GED.
• 2 years of related experience in pharmaceutical or medical device manufacturing for roles in the Formulation Department.
• 2 years of experience working in a laboratory environment, including basic math skills and comfort working with toxic chemicals, for roles in the second department.
• 1 year of related experience in pharmaceutical or medical device manufacturing for roles in the Vialing Department.
• Experience with assembly work in a cleanroom or manufacturing environment.
• Hands-on experience in medical device or pharmaceutical manufacturing.
• Experience working in a laboratory or chemical handling environment, including at least 2 years working with chemicals for certain roles.
• Familiarity with GMP (Good Manufacturing Practices) and aseptic techniques.
• Ability to follow SOPs, packaging procedures, and sanitization requirements.
• Ability to operate laboratory and production equipment such as mixers, jacketed tanks, peristaltic pumps, ultrasonic baths, bottle rollers, balances, pipettes, and micro balances.
• Ability to read, complete, and maintain batch records, lot history records, and controlled documentation accurately.
• Comfort working with toxic chemicals and powders while following appropriate PPE and safety protocols.
• Strong attention to detail and accuracy in documentation, measurements, and inspections.

Additional Skills & Qualifications

• Previous experience in a cleanroom or controlled manufacturing environment.
• Experience with formulation of polymers and spray coating formulations.
• Experience setting up and operating coating machines and handling balloon catheters.
• Familiarity with environmental controls and line clearance procedures.
• Experience with in-process inspections and data analysis in a manufacturing or laboratory setting.
• Comfort using microscopes for detailed product inspection.
• Ability to troubleshoot basic product and process issues and communicate findings to supervision or engineering.
• Strong organizational skills and the ability to manage multiple tasks within defined schedules.
• Basic math proficiency to support weighing, measuring, and solution preparation.
• Ability to work variable shifts, including early mornings and occasional Saturdays, as required by department schedules.

Why Work Here?

You will contribute directly to the development and production of advanced drug-device combination products that address critical medical needs in coronary and peripheral artery disease. The organization focuses on next-generation healthcare solutions and offers the opportunity to work with innovative technologies in a highly regulated, quality-driven environment. You will join a globally oriented company with an international footprint, providing exposure to best practices and collaboration across multiple regions. The culture emphasizes mission-driven work, continuous improvement, and adherence to high standards of safety and compliance, supporting both professional growth and meaningful impact on patient care.

Work Environment

The role is based in a cleanroom and manufacturing environment that operates under strict GMP and aseptic standards. You will work with pharmaceutical assemblies, medical devices, and drug-loaded polymer microspheres using equipment such as mixers, jacketed tanks, temperature control units, peristaltic pumps, ultrasonic baths, bottle rollers, balances, pipettes, and micro balances. The Formulation Department offers a first-shift schedule, typically from 2:30 a.m. to 11:00 a.m., with some Saturdays as needed. Another department operates on a structured weekday schedule, including 6:00 a.m. to 2:30 p.m. on certain days, variable shifts such as 6:00 a.m. to 2:30 p.m. or 12:00 p.m. to 8:30 p.m. on Wednesdays, and 9:00 a.m. to 5:30 p.m. on Thursdays, with shift differentials applicable to some shifts. You will work in controlled cleanroom conditions that require consistent use of PPE, adherence to sanitization procedures, and compliance with line clearance and safety protocols. The environment involves handling toxic chemicals and powders in a laboratory setting, emphasizing careful attention to safety, cleanliness, and documentation.

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 26, 2026.