Cleanroom Production Operator
16 hours ago
San Diego
Job DescriptionJob Title: Cleanroom Production Operator Job Description The Cleanroom Production Operator supports daily production and packaging activities in a regulated manufacturing environment, working in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs). This role focuses on achieving production goals, maintaining product quality, and ensuring accurate documentation while operating in a cleanroom setting. Responsibilities • Perform daily production and packaging activities in strict accordance with GMP and all relevant SOPs., • Work consistently to achieve assigned production goals and respond to unscheduled peaks in workload to ensure timely product release and prevent back orders., • Collaborate with the Team Leader and other stakeholders to understand critical raw materials, in-process procedures, and product specifications., • Assist in identifying and implementing corrective actions for technical problems related to raw materials and finished products., • Perform in-process quality checks on sub-assemblies and finished products to ensure compliance with specifications and quality standards., • Identify and troubleshoot line issues and other production problems, and promptly notify the Team Leader or appropriate personnel of required corrective actions., • Maintain accurate, complete, and legible records and documentation in accordance with Good Documentation Practices (GDP) and related SOPs., • Use a computerized Materials Resource Planning (MRP) or Enterprise Resource Planning (ERP) inventory system as required to report lot-controlled ingredients on batch records., • Operate production machinery and equipment safely and efficiently while following all manufacturing procedures., • Support qualification and validation activities as needed, following established protocols and documentation requirements., • Close work orders accurately and on time, ensuring all associated documentation and system entries are complete., • Participate in training and ongoing learning to quickly comprehend and support coagulation-based manufacturing processes., • Follow all cleanroom, safety, and quality procedures, including the correct use of personal protective equipment and adherence to facility rules., • Communicate clearly with supervisors and team members about production status, issues, and improvement opportunities., • Demonstrate reliable attendance and punctuality to prevent bottlenecks in the production process.Essential Skills, • At least two (2) years of previous assembly or packaging experience., • Previous experience in a regulated medical device manufacturing or pharmaceutical environment strongly preferred., • Demonstrated ability to understand and follow SOPs, including the ability to explain how SOPs were used in a prior role to achieve production and quality goals., • Strong understanding of Good Documentation Practices (GDP) and the ability to explain how GDP was applied in previous positions., • Familiarity with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), FDA regulations, and ISO standards., • Ability to quickly comprehend coagulation-based manufacturing processes., • Experience with machine operation in a production environment., • Experience with quality assurance, packaging, inspection, and computer operation in a manufacturing setting., • Working knowledge of Microsoft Office applications., • Experience with large Enterprise Resource Planning (ERP) systems, such as SAP or similar platforms., • Ability to use computerized Materials Resource Planning (MRP) systems to record and track lot-controlled materials., • Strong attention to detail and accuracy in documentation and recordkeeping., • Ability to work flexible hours, including overtime and occasional Saturdays, as required., • Reliable attendance and strong sense of responsibility to support continuous production flow.Additional Skills & Qualifications, • Previous experience in medical device or pharmaceutical manufacturing involving coagulation-based processes., • Knowledge of qualification and validation trials and participation in related activities., • Familiarity with additional manufacturing acronyms and terminology, demonstrating comfort with manufacturing lingo., • Experience closing work orders and documenting production activities in ERP or MRP systems., • Ability to clearly describe machines operated, computer systems used, and prior experience with systems such as SAP., • Comfort working in a regulated cleanroom environment with strict procedural and documentation requirements., • Strong communication skills to effectively interact with team members, supervisors, and cross-functional partners., • Demonstrated ability to learn new processes and reach higher levels of responsibility as an operator.Why Work Here? The organization invests in each employee’s growth and integration into the team, including those in contract roles. Employees are invited to quarterly company events, often featuring catered lunches and shared celebrations that foster a sense of community. Upon conversion to a permanent role, individuals receive a pay increase, reflecting recognition of their contributions and development. The culture emphasizes reliability, teamwork, and ongoing learning, offering opportunities to advance skills, take on additional responsibilities, and build a long-term career in a regulated manufacturing environment. Work Environment This position is based in a cleanroom manufacturing environment on the second shift, typically from 1:30 p.m. to 10:00 p.m. Work is performed on the production floor with exposure to machinery and equipment, and the area can be loud at times; hearing protection and earplugs are provided as needed. The environment follows strict GMP, SOP, and GDP requirements, as well as FDA and ISO guidelines, and involves use of computers, MRP/ERP systems, and production equipment. The dress code requires pants (leggings are not permitted), and no makeup or lipstick may be worn in the cleanroom. If necklaces are worn, they must be tucked into the shirt. Glasses must be used with side shields while on the manufacturing floor. Headphones are not allowed on the floor, and cell phone use is restricted to maintain focus and safety. After an initial training period of approximately six weeks, overtime may be required; some overtime is voluntary and some may be mandatory, with one to two weeks’ notice provided. Flexibility to work overtime, including potential Saturday shifts, is important. Reliability and consistent attendance are critical, as the absence of a single team member can create bottlenecks in the production process. Job Type & Location This is a Contract 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 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.