Manufacturing Technician
3 days ago
Irvine
Job DescriptionJob Title: Manufacturing Technician Job Description This role is responsible for manufacturing pharmaceutical and medical device assemblies in a regulated GMP environment. The position supports multiple departments, including Formulation, a solutions-focused department, and a Vialing department, and involves tasks such as solution preparation, equipment setup and operation, in‑process testing, packaging, and accurate documentation of manufacturing activities. Responsibilities • Perform setup, verification, and teardown of manufacturing equipment before and after processing to ensure proper operation and compliance with procedures., • Prepare solutions and production materials, including weighing, mixing, heating, cooling, sampling, filtration, and handling of raw materials according to detailed instructions., • Execute manufacturing tasks such as fabrication, in‑process testing, packaging, and sterilization preparation of pharmaceutical and medical device products., • Formulate polymers and spray coating formulations, including preparation of excipient and spray coating solutions used in coating processes., • Set up coating machines and coat, inspect, and fold balloon catheters and other delicate medical device components with precision and care., • Support the preparation, mixing, inspection, filtration, and documentation of solutions used in the production of drug‑loaded polymer microspheres., • Operate a variety of equipment such as mixers, jacketed tanks, temperature control units (TCU), peristaltic pumps, ultrasonic baths, bottle rollers, balances, pipettes, micro balances, and coating machines., • Perform in‑process inspections and environmental controls to ensure products and processes meet defined specifications and quality standards., • Conduct basic visual inspections using microscopes or magnification tools to verify product quality and identify defects., • Document production activities accurately in manufacturing lot history records, batch records, and controlled documentation, following Good Documentation Practices (GDP)., • Follow detailed work instructions, standard operating procedures (SOPs), cleanroom practices, and line clearance requirements to maintain compliance with GMP and company standards., • Clean and maintain production equipment, workstations, tools, and production areas in accordance with 5S, sanitization, and GMP requirements., • Utilize pipettes and micro weight equipment to perform precise measurements and support accurate formulation activities., • Perform analysis of data as needed to support process monitoring, troubleshooting, and continuous improvement efforts., • Follow personal protective equipment (PPE) and safety requirements, including working safely with toxic chemicals and powders in a laboratory and cleanroom environment., • Escalate deviations, out‑of‑specification results, equipment malfunctions, or material shortages promptly to supervision or engineering for timely resolution., • Operate machinery to produce medical devices that meet defined specifications, following manufacturing instructions and updating job documentation accurately for traceability., • Participate in basic problem‑solving and continuous‑improvement activities to enhance product quality, process efficiency, and safety., • Support adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), aseptic techniques, and all company safety procedures across all assigned operations.Essential Skills, • Experience working in a cleanroom or regulated manufacturing environment, preferably in pharmaceutical or medical device production., • Minimum of 2 years of medical device or pharmaceutical manufacturing experience for roles in the Formulation Department., • Minimum of 2 years of experience working with chemicals in a laboratory or manufacturing setting for roles in the solutions-focused department, including comfort working with toxic chemicals and powders., • Minimum of 1 year of related experience in pharmaceutical or medical device manufacturing for roles in the Vialing Department., • Demonstrated ability to follow GMP, GDP, SOPs, aseptic techniques, and cleanroom practices consistently., • Proficiency in preparing solutions, including weighing, mixing, heating, cooling, sampling, and filtration, with strong attention to accuracy and detail., • Ability to operate manufacturing and laboratory equipment such as mixers, jacketed tanks, TCUs, peristaltic pumps, ultrasonic baths, bottle rollers, balances, pipettes, micro balances, and coating machines., • Skill in handling delicate medical device components and performing inspections using microscopes or magnification tools., • Strong documentation skills, including accurate completion of batch records, lot history records, and other controlled documents., • Basic math skills and the ability to perform calculations required for solution preparation, measurements, and data recording., • Ability to troubleshoot product and process-related issues and escalate concerns appropriately., • Commitment to safety, including adherence to PPE requirements and safe handling of chemicals and equipment.Additional Skills & Qualifications, • High School Diploma or GED., • For Formulation Department roles: at least 2 years of related experience in pharmaceutical or medical device manufacturing., • For solutions-focused department roles: at least 2 years of experience working in a laboratory environment, with basic math skills and comfort working with toxic chemicals., • For Vialing Department roles: at least 1 year of related experience in pharmaceutical or medical device manufacturing., • Experience with medical device and pharmaceutical assembly, packaging, and sterilization preparation., • Familiarity with aseptic techniques, aseptic handling, and sanitization procedures in a cleanroom environment., • Experience working with chemical processes, polymers, and spray coating formulations., • Ability to read, understand, and follow detailed work instructions, SOPs, and manufacturing instructions., • Strong organizational skills and the ability to maintain a clean, orderly, and compliant work area., • Comfort working across different shifts, including early morning, mid‑day, and occasional Saturday work as needed.Why Work Here? The organization focuses on developing advanced drug-device combination products that address critical and unmet medical needs, offering the opportunity to contribute to next-generation healthcare solutions. Team members work within a global environment that values innovation, quality, and continuous improvement, with operations spanning multiple international locations. The culture emphasizes collaboration, safety, and professional growth, providing a setting where employees can build their skills while supporting life-changing medical technologies. Work Environment The role is based in a cleanroom and manufacturing environment that follows strict GMP, GDP, aseptic, and safety standards. Work is performed in designated departments with defined shift schedules, such as 11:00 a.m.–7:30 p.m. with occasional Saturdays for the Formulation Department, early morning shifts such as 5:00 a.m.–1:30 p.m. on certain weekdays with a mid‑day shift on others for the solutions-focused department, and 6:00 a.m.–2:30 p.m. with some Saturdays as needed for the Vialing Department. Employees work with mixers, jacketed tanks, temperature control units, peristaltic pumps, ultrasonic baths, bottle rollers, balances, pipettes, micro balances, coating machines, and other production equipment. The environment involves handling chemicals, polymers, toxic powders, and delicate medical device components in a cleanroom setting, with required use of PPE and adherence to line clearance, cleaning, and sanitization procedures. Workstations and production areas follow 5S principles and are maintained to high standards of cleanliness and organization to support product quality and regulatory compliance. 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 Jun 23, 2026. About Aerotek We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies’ construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow. Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. Company DescriptionWe know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.