Manufacturing Associate Level 2 at US02 Lonza Biologics Inc. in Hayward, California

Job Description:

Posted Job Advert

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Manufacturing Associate Level II is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level II associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, independently perform laboratory tasks, including pH, conductivity testing, product sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to demonstrate a strong understanding of cGMP compliance while operating under supervision, and aseptic technique in handling of products and materials. Level II Operators may also be asked to troubleshoot equipment events, initiate deviations, review batch records and logbooks.

Key Responsibilities:

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  Set up, operate equipment, and monitor production processes, including report production in written and electronic documents in accordance with good documentation procedures (GDPs), troubleshooting issues and review documentation as appropriate.

  
  


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  Train other personnel on equipment operation, cGMPs, documentation, technical theory, or other tasks. Maintain individual training plan.

  
  


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  Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required.

  
  


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  Administrative tasks – leading shift exchange, meetings, sending/receiving emails, participating in projects.

  
  


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  Use sophisticated laboratory instrumentation and computer systems to collect and record data.

  
  


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  Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations.

  
  


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  Perform other duties as assigned.

  
  

Key requirements:

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  High School Diploma or Equivalent minimum; AS/BS preferred

  
  


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  Preferred area of study:  Science related discipline

  
  


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  Intermediate to Advanced years’ experience in manufacturing; GMP setting preferred, and/or at least 6 months experience as an Associate Level I in bio-pharm industry.

  
  


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  Proven logic and decision making abilities, critical thinking skills

  
  


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  Strong written and verbal communication skills are required

  
  


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  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.

  
  

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility.  How we achieve our business results is just as important as the achievement themselves.  At Lonza, we respect and protect our people and our environment.  Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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.