Manufacturing Associate I
Lonza, Inc. Hayward, CA
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. Our vision: We strive to be the leading supplier using science and technology to improve the quality of life. Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization? Job Description Summary Overview/Role Purpose: The Manufacturing Associate Level I is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials. Key Accountabilities and Duties: •Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good documentation procedures (GDPs), review documentation as appropriate •Attain qualification for all assigned tasks and maintain individual training plan •Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc. •Perform material movements, transfer raw materials, chemicals into, out of, across the production areas. •Maintain facility and equipment through routine cleaning and sanitization, support 6S programs •Office tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects •Conduct environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms manufacturing facilities along with Product Process monitoring, Gas testing and Water collection. •Perform microbial and particulate monitoring of clean rooms throughout the facility; including personnel monitoring of gowns and gloves. •Use sophisticated laboratory instrumentation and computer systems to collect and record data. •Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. The role of the Manufacturing Associate I is to support manufacturing processes in the upstream and downstream process (USP and DSP) as necessary. Work Schedule 4 days a week, 10 hours shift (4/10s) or 5 days a week, 8 hours shift (5/8s) or per business needs (Day or Swing) Primary Accountabilities, Duties and Responsibilities Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate Attain qualification for all assigned tasks and maintain individual training plan Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, Perform material movements, transfer raw materials, chemicals into, out of, across the production areas. Maintain facility and equipment through routine cleaning and sanitization, support 6S programs Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects, perform other duties as assigned. Perform other duties as assigned. Essential Job Functions The demands described below are those essential functions that an employee must be able to accomplish in order to perform this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Marginal or non-essential functions should not be listed. Please note that regular and reliable attendance is an essential function of every position and should not be listed separately below. Safety Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety and the safety of others. Quality Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Environmental Demands: The normal working environment is: Production Floor setting, requiring PPE, gowning, safety shoes and glasses. Physical Demands JOB REQUIRES Continuous Frequent Occasional Part of day 100%-67% 66%-34% 33%-1% Bending X Kneeling X Squatting X Climbing stairs X Climbing ladders X Walking X Sitting X Reaching X Driving X Fine motor skills X Gowning X Standing X Lifting 25lbs 60lbs Mental Demands: Must have the ability to comprehend process flow and identify factors which influence the process. Must be able to read and follow defined SOPs and policies, work independently on basic manufacturing tasks, identify and communicate non-routine events, and review more complex decisions with Supervisors. Must be able to use automated process equipment and tools. Minimum Required Qualifications/Skills High School Diploma or Equivalent minimum; AS/BS preferred. Preferred area of study: Science related discipline Entry level to Intermediate years’ experience; some prior experience in a manufacturing setting preferred. Proven logic and decision making abilities, critical thinking skillsStrong written and verbal communication skills are required The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities. Is open to and actively seeks out feedback on their performance and translates that feedback into action. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. Lonza. The place to Go, Stay and Grow.