Medical Device Machine Operator - 1st Shift - $19/hr - 92121 Zip Code
Job Description
The Cleanroom Technician supports daily production and packaging activities in a regulated manufacturing environment, ensuring all work complies with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). This role focuses on achieving production goals, maintaining high-quality standards, and accurately documenting all activities in alignment with Good Documentation Practices (GDP). The technician operates within a cleanroom setting, performs in-process quality checks, and uses computerized systems to manage materials and production records.
Responsibilities
Perform daily production and packaging activities in accordance with GMP and all relevant SOPs.
Work consistently to achieve assigned production goals and respond to unscheduled peaks in workload to support timely product release and prevent back orders.
Collaborate with the Team Leader and other stakeholders to understand and follow requirements for critical raw materials, in-process procedures, and product specifications.
Identify technical issues related to raw materials and finished products and assist in implementing appropriate corrective actions.
Conduct in-process quality checks on sub-assemblies and finished products to ensure they meet established standards and specifications.
Recognize and troubleshoot line issues and other production problems, promptly notifying the Team Leader or appropriate personnel of required corrective actions.
Maintain accurate, complete, and legible records and documentation in accordance with GDP and all applicable SOPs.
Use a computerized Materials Resource Planning (MRP) system to report lot-controlled ingredients and accurately document information on batch records.
Perform line clearances and verify that equipment, materials, and documentation are properly reset and ready for the next production run, providing accurate examples of prior experience when needed.
Operate production and packaging machinery safely and efficiently while adhering to established operating procedures.
Support quality assurance activities, including inspection of components, in-process materials, and final products.
Follow Good Laboratory Practices (GLP), GMP, FDA, and ISO-related requirements as applicable to the manufacturing processes.
Assist with or support qualification and validation trials as needed.
Use computer systems, including Microsoft Office and Enterprise Resource Planning (ERP) tools, to complete production-related tasks, close work orders, and maintain accurate records.
Demonstrate reliability and consistent attendance to prevent bottlenecks in the production process.
Participate in training to qualify for overtime assignments and remain flexible to work additional hours, including some Saturdays, when required.
Essential Skills
At least four years of previous assembly and packaging experience in a manufacturing environment.
Previous experience in a regulated medical device manufacturing or pharmaceutical environment strongly preferred.
Strong understanding of SOPs, including the ability to clearly explain what SOPs are and how they are applied in a manufacturing environment.
Proven ability to follow SOPs and provide detailed examples of how they were used to achieve production or quality goals in prior roles.
Solid understanding of GDP, including the ability to explain what Good Documentation Practices are and how they are followed in day-to-day work.
Knowledge of GMP and how it applies to manufacturing operations.
Experience performing line clearances and the ability to describe accurate examples of prior line clearance activities.
Hands-on experience with machine operation in a production or packaging environment.
Experience in quality assurance, packaging, inspection, and computer operation within a manufacturing setting.
Ability to work with MRP or ERP systems to record lot-controlled materials and close work orders.
Working knowledge of Microsoft Office applications.
Ability to quickly comprehend coagulation-based manufacturing processes or similar complex production processes.
Familiarity with GDP, GMP, GLP, FDA, and ISO requirements.
Strong reliability, attention to detail, and commitment to following procedures accurately.
Ability to communicate using manufacturing terminology and acronyms, demonstrating understanding of manufacturing lingo.
Additional Skills & Qualifications
Previous experience in coagulation-based manufacturing processes or related production environments.
Knowledge of qualification and validation trials and prior involvement in such activities is a plus.
Experience using large Enterprise Resource Planning (ERP) systems; prior experience with SAP or similar platforms is beneficial.
Comfort working in a cleanroom environment with strict procedural and documentation requirements.
Ability to describe machines previously operated, computer systems used, and production processes supported during interviews.
Familiarity with Good Laboratory Practices (GLP), FDA regulations, and ISO standards.
Ability to adapt to overtime schedules, including occasional Saturday work, depending on production needs.
Strong problem-solving skills for addressing technical issues related to raw materials, finished products, and production lines.
Why Work Here?
The organization invests in each employee's growth and engagement, including those in contract roles. Team members are invited to participate in quarterly company events, often featuring catered lunches and social gatherings, fostering a sense of inclusion and community. Upon conversion to a permanent role, employees receive a pay increase, reflecting recognition of their contributions and commitment. The culture emphasizes reliability, teamwork, and continuous learning in a structured, regulated environment, offering opportunities to deepen manufacturing and quality expertise.
Work Environment
This role is based in a cleanroom manufacturing environment on a first-shift schedule, typically from 6:00 a.m. to 2:30 p.m. Work is performed on the production floor around machinery and equipment, and it can become loud; hearing protection and earplugs are provided as needed. The dress code requires pants (leggings are not permitted), and no makeup or lipstick may be worn in the cleanroom to maintain product and environmental integrity. If necklaces are worn, they must be tucked into shirts. Employees who wear glasses must use side shields while on the manufacturing floor. Headphones are not allowed on the manufacturing floor, and cell phone use is restricted to maintain safety and focus. The environment is highly regulated, with strict adherence to GMP, SOPs, and GDP, and involves regular use of computers, including MRP and ERP systems, to manage work orders and production data. Overtime may be required after an initial training period of approximately six weeks, with some overtime being voluntary and some mandatory; schedules, including possible Saturday work, are communicated one to two weeks in advance. Reliability and consistent presence are critical, as the absence of a single team member can create bottlenecks in the production process.
Job Type & Location
This is a Contract to Hire position based out of San Diego, CA.
Pay and Benefits
The pay range for this position is $19.00 - $19.00/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 San Diego,CA.
Application Deadline
This position is anticipated to close on Jun 29, 2026.
About Aerotek
Aerotek® Inc. provides staffing and services solutions in manufacturing, logistics, construction, aviation, facilities and maintenance. We provide the expertise, solutions and people required to rise to the challenges of North American industry. Headquartered in Hanover, Md., Aerotek operates a unified network of over 200 offices across North America, supporting more than 18,000 clients each year. Aerotek is an Allegis Group company, the global leader in workforce and business solutions. To learn more, visit: Aerotek.com | 1-888-AEROTEK.
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.
