Cleanroom Technician
hace 3 días
San Diego
Job Description Job Title: Cleanroom Technician Job Description The Cleanroom Technician supports daily production and packaging activities in a regulated manufacturing environment, following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and all related standard operating procedures (SOPs). This role focuses on achieving production goals, maintaining high-quality standards, accurately documenting work, and using computerized systems to manage materials and batch records. Responsibilities • Perform daily production and packaging activities in a cleanroom environment in accordance with GMP and all relevant 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 the Team Leader and other production staff to understand and follow requirements for critical raw materials, in-process procedures, and product specifications., • Identify technical problems related to raw materials and finished products and support appropriate corrective actions., • Perform in-process quality checks on sub-assemblies and finished products to verify they meet defined quality standards., • Recognize line issues and other production problems and promptly notify the Team Leader or appropriate personnel of required corrective actions., • Perform and document line clearances, ensuring production lines are properly cleared, verified, and ready between batches or product changes., • Maintain accurate, legible, and complete records and documentation in accordance with GDP and all related SOPs., • Use a computerized Materials Resource Planning (MRP) or Enterprise Resource Planning (ERP) system as required to report lot-controlled ingredients on batch records and close work orders., • Operate production machinery and equipment safely and efficiently, following established procedures and work instructions., • Conduct visual and functional inspection of products and packaging to identify defects or nonconformances., • Follow quality assurance procedures and support qualification and validation activities as needed., • Adhere strictly to cleanroom, safety, and gowning protocols, including applicable dress code and personal protective equipment requirements., • Use computers and basic software tools to enter data, complete electronic records, and support production and quality activities., • Communicate effectively with supervisors and team members about production status, issues, and improvement opportunities., • Demonstrate reliability by maintaining consistent attendance and punctuality to avoid bottlenecks in the production process., • 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., • Solid understanding of Standard Operating Procedures (SOPs), including what they are, why they are used in manufacturing, and how to follow them to meet production and quality goals., • Ability to clearly explain past experience using SOPs and provide detailed examples of how they were followed in previous roles., • Strong understanding of Good Documentation Practices (GDP), including the ability to explain what GDP is and how to apply it in daily work., • Hands-on experience performing line clearances, with the ability to give accurate examples of how line clearances were completed and documented., • Experience with machine operation in a production or cleanroom environment., • Knowledge and practical application of Good Manufacturing Practices (GMP)., • Ability to perform basic computer operations and use production-related software systems., • Previous experience with, or the ability to quickly comprehend, coagulation-based manufacturing processes., • Familiarity with GDP, GMP, Good Laboratory Practices (GLP), FDA regulations, and ISO standards., • Knowledge of 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., • Ability to use a computerized Materials Resource Planning (MRP) system to track and report lot-controlled ingredients., • Comfort using manufacturing terminology and acronyms, demonstrating an understanding of common manufacturing concepts and lingo., • Experience closing work orders and documenting production activities in electronic systems., • Strong attention to detail, especially when performing inspections and completing documentation. The organization invests in each employee and values the contributions of both permanent team members and contractors. Team members are included in quarterly company events, which typically feature catered lunches and food provided on-site, fostering a sense of community and recognition. Upon conversion to a permanent role, employees receive a pay increase, reflecting the company’s commitment to growth and long-term career development. The culture emphasizes inclusion in team activities, recognition for reliable performance, and opportunities to advance and expand skills within a regulated manufacturing environment. Work Environment This position is based in a cleanroom manufacturing environment on the 2nd shift. Work takes place on a production floor that can become loud at times, and hearing protection such as earplugs or other ear protection is provided. Employees work with production machinery, inspection tools, computers, and systems such as MRP or ERP (potentially including SAP) to support manufacturing and documentation activities. The role may require overtime after an initial training period of approximately six weeks, with some overtime being voluntary and some mandatory; overtime schedules, including potential Saturday work, depend on the specific position and production needs. Reliability is critical, as missing team members can create bottlenecks in the process. The dress code requires pants (leggings are not permitted), and no makeup or lipstick can be worn. If necklaces are worn, they must be tucked into the shirt. Employees who wear glasses must use side shields while on the manufacturing floor. Headphones are not allowed on the manufacturing floor, and personal cell phone use is restricted in production areas to maintain safety, focus, and product quality. 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 $23.10 - $23.10/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. 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.