Cleanroom Production Operator

Cleanroom Production Operator

The Cleanroom Production Operator performs daily production and packaging activities in a controlled manufacturing environment, following Good Manufacturing Practices (GMP) and all relevant standard operating procedures (SOPs). This role focuses on meeting production goals, supporting timely product release, and maintaining high quality standards through accurate documentation, in-process checks, and effective use of manufacturing and inventory systems.

Responsibilities

• Perform daily production and packaging activities in accordance with Good Manufacturing Practices (GMP) and all applicable standard operating procedures (SOPs).
• Work consistently to achieve assigned production goals and support unscheduled peaks in workload to ensure timely release of product and prevent back orders.
• Collaborate with team leadership to understand and follow critical raw material requirements, in-process procedures, and product specifications.
• Identify technical issues related to raw materials and finished products and take appropriate corrective actions in alignment with established procedures.
• Conduct in-process quality checks on sub-assemblies and finished products to ensure compliance with specifications and quality standards.
• Recognize and address line issues and other production problems, promptly notifying team leadership of required corrective actions.
• Maintain accurate, complete records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs.
• Use computerized Materials Resource Planning (MRP) and Enterprise Resource Planning (ERP) systems, as required, to report and track lot-controlled ingredients on batch records and close work orders.
• Perform line clearances and document them accurately to ensure that production lines are ready for the next batch or product.
• Operate production machinery and equipment safely and efficiently, following all operational instructions and SOPs.
• Carry out packaging and inspection activities, ensuring products meet quality and regulatory requirements.
• Follow Good Laboratory Practices (GLP), FDA, and ISO-related procedures as applicable to the production environment.
• Use computers and Microsoft Office applications to enter data, complete forms, and support production and documentation activities.
• Participate in training to qualify for additional cleanroom and manufacturing responsibilities, including overtime and weekend work when needed.
• Demonstrate reliability and consistent attendance, understanding that missing personnel can create bottlenecks in critical manufacturing processes.

Essential Skills

• Ability to work in a cleanroom production environment and follow GMP, GDP, SOP, GLP, FDA, and ISO-related practices.
• Understanding of what SOP (Standard Operating Procedure) means in a manufacturing environment and ability to explain how SOPs were followed in previous roles to achieve goals.
• Understanding of Good Documentation Practices (GDP) and ability to describe how accurate documentation was maintained in prior positions.
• Capability to perform line clearances and provide clear, accurate examples of this experience.
• Basic machine operation skills in a manufacturing or production setting.
• Experience or strong aptitude for quality assurance, packaging, and inspection activities.
• Ability to operate computers for production, documentation, and inventory tasks.
• Familiarity with GMP requirements and how they apply to daily manufacturing operations.
• Previous experience with, or ability to quickly comprehend, coagulation-based manufacturing processes.
• Familiarity with qualification and validation trials is a plus.
• Working knowledge of Microsoft Office applications.
• Experience with large Enterprise Resource Planning (ERP) systems, such as SAP, is preferred.
• Entry-level candidates are welcome; no prior experience is required if the candidate can clearly demonstrate understanding of manufacturing SOPs and documentation practices.

Additional Skills & Qualifications

• Ability to explain other common manufacturing acronyms, demonstrating comfort with manufacturing terminology and lingo.
• Experience using Materials Resource Planning (MRP) systems to report lot-controlled ingredients on batch records.
• Experience closing work orders and documenting production activities in ERP systems.
• Prior exposure to coagulation-based or similar regulated manufacturing processes is beneficial.
• Familiarity with qualification and validation trials in a manufacturing or laboratory environment is advantageous.
• Comfort working with quality assurance processes and inspection criteria in a regulated setting.
• Ability to describe previous experience with machines operated and computer systems used, including any experience with SAP.
• Strong reliability and punctuality, with an understanding of how individual attendance impacts overall production flow.
• Willingness and flexibility to work overtime, including occasional Saturdays, based on production needs.

Why Work Here?

• The organization invests in each employee, offering a supportive culture where both permanent staff and contractors are included in regular company events and celebrations. Team members are invited to quarterly company gatherings, often featuring catered lunches and food in a relaxed outdoor setting. As employees grow in the role and transition from contract to permanent status, they can look forward to a pay increase upon conversion, reflecting the value placed on long-term contribution and development. The environment emphasizes training, skill-building, and advancement, creating opportunities to progress to higher responsibility levels over time.

Work Environment

• This position is based in a cleanroom manufacturing environment on the second shift, typically from 2:00 p.m. to 10:30 p.m. Work takes place on a production floor where machinery and equipment are in operation and noise levels can be high; ear protection and ear plugs are provided as needed. Headphones are not permitted on the manufacturing floor, and personal cell phone use is restricted during work time to maintain safety and focus. The dress code requires full-length pants; leggings are not allowed. Makeup and lipstick cannot be worn in the cleanroom to maintain product and environmental integrity. Necklaces must be tucked inside shirts, and if glasses are worn, side shields are required. The role involves working with computers, MRP and ERP systems, and production equipment in a regulated environment. Some overtime may be voluntary and some mandatory, with advance notice typically given one to two weeks before it is required. Flexibility to work occasional Saturdays may be needed, and reliability is crucial, as the absence of even one person 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 $20.35 - $20.35/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 Aug 1, 2026.