Manufacturing Associate - Cleanroom
hace 2 días
San Diego
Job Description Manufacturing Associate - Medical Device - 1st, 2nd, 3rd Shift 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), Good Documentation Practices (GDP), and standard operating procedures (SOPs). This role focuses on achieving production goals, maintaining product quality, and accurately documenting all activities while working in a cleanroom setting with strict safety and cleanliness standards. Responsibilities • Perform daily production and packaging activities in accordance with GMP and all applicable SOPs., • Work consistently to achieve assigned production goals and support unscheduled workload peaks 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., • Identify technical issues related to raw materials and finished products and assist in implementing appropriate corrective actions., • Perform in-process quality checks on sub-assemblies and finished products to verify compliance with specifications., • Recognize line issues and other production problems and promptly notify the Team Leader or appropriate personnel for corrective action., • Maintain accurate, complete, and legible records and documentation in accordance with GDP and related SOPs., • Use a computerized Materials Resource Planning (MRP) or Enterprise Resource Planning (ERP) system to report lot-controlled ingredients and accurately complete batch records., • Perform line clearances and verify that equipment, materials, and documentation are correctly set up and cleared between production runs., • Operate manufacturing and packaging machinery safely and efficiently, following all SOPs and work instructions., • Support qualification and validation activities as needed by following defined protocols and documenting results., • Adhere to Good Laboratory Practices (GLP), FDA, ISO, and other relevant regulatory and quality standards as required., • Follow cleanroom protocols, including gowning procedures, cleanliness standards, and restrictions on personal items and cosmetics., • Use computers and related systems to close work orders and document production activities accurately., • Participate in overtime and weekend work as needed, including potential Saturday shifts, based on production demands., • Demonstrate reliable attendance and punctuality to avoid bottlenecks in the production process and maintain workflow continuity. 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 standard operating procedures (SOPs), including the ability to explain what SOPs are and how they are applied in a manufacturing environment., • Ability to provide detailed examples of how SOPs were followed in prior roles to achieve production and quality goals., • Solid understanding of Good Documentation Practices (GDP), including the ability to explain GDP and describe how they were applied in previous positions., • Working knowledge of Good Manufacturing Practices (GMP) and their application in daily production activities., • Familiarity with Good Laboratory Practices (GLP), FDA regulations, and ISO standards., • Ability to perform line clearances and provide accurate examples of prior line clearance responsibilities., • Experience with machine operation in a production or packaging environment., • Experience with quality assurance, inspection, and in-process quality checks., • Computer operation skills, including the ability to use MRP or ERP systems to record lot-controlled ingredients and close work orders., • Working knowledge of Microsoft Office applications., • Previous experience with, or the ability to quickly comprehend, coagulation-based manufacturing processes., • Strong attention to detail and accuracy in documentation and record-keeping., • Ability to understand and use manufacturing terminology and acronyms, demonstrating familiarity with manufacturing lingo., • Reliability and strong work ethic, with the ability to support overtime and flexible scheduling as required. Additional Skills & Qualifications • Experience in a regulated medical device or pharmaceutical manufacturing environment., • Familiarity with qualification and validation trials and the ability to follow related protocols., • Experience working with large Enterprise Resource Planning (ERP) systems, such as SAP or similar platforms., • Ability to describe prior experience with specific machines, equipment, and computer systems used in production., • Comfort working in a cleanroom environment with strict cleanliness and contamination-control requirements., • Strong communication skills, including the ability to clearly explain processes, SOP usage, and documentation practices to supervisors and interviewers., • Ability to adapt to changing production priorities and support unscheduled workload peaks., • Demonstrated capability to grow into higher-level operator responsibilities over time. Why Work Here? The organization invests in each employee’s growth and engagement, including contractors, who are welcomed into the broader team culture. Team members participate in quarterly company events, often featuring catered lunches and social activities that foster connection and appreciation. When employees convert from contract to permanent roles, they receive a pay increase, reflecting the company’s commitment to recognizing performance and long-term contribution. The environment emphasizes reliability, collaboration, and professional development, offering opportunities to expand skills in a regulated manufacturing setting. Work Environment This role is based in a cleanroom manufacturing environment on first shift, with two openings available for a 6:00 a.m. to 2:30 p.m. schedule. The setting can be loud at times, and ear protection and ear plugs are provided; personal headphones are not permitted on the manufacturing floor, and cell phone use is restricted during work. The position involves working around production machinery, computers, and systems such as MRP and ERP platforms, including potential use of SAP. Dress code requirements include wearing pants (leggings are not permitted), no makeup or lipstick, and any necklaces must be tucked into shirts. If glasses are worn, side shields are required for additional protection. The role may involve overtime after an initial training period of approximately six weeks, with some overtime being voluntary and some mandatory, and may include Saturday work depending on production needs. Employees are expected to maintain strict adherence to cleanroom protocols, safety rules, and documentation standards to ensure product quality and regulatory compliance. 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 Jul 31, 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. 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.