NIGHTS Biotech Manufacturing Associates - GMP/Cleanroom

• Week 1: MON/TUE/FRI/SAT/SUN

• Week 2: WED/THUR

• Nights includes 20% shift differential

• Shift differentials are included for weekends worked

• Initial 2-week training period on day shift Monday-Friday for new hires

• Annual bonus included

The Biotechnologist/Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) under current Good Manufacturing Practices (cGMP) conditions. Level I associates are expected to execute process recipes, follow written Standard Operating 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

• 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), troubleshooting issues and review documentation as appropriate.

• Attain qualification for all assigned tasks and maintain individual training plan.

• Demonstrate proficiency at laboratory tasks, such as monitoring pH, conductivity, product sampling etc. May train Level 1 Associates on these tasks.

• Perform material movements, transfer materials and chemicals in, out, and 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.

Key Requirements

• High School Diploma or Equivalent minimum; AS/BS preferred;

• Preferred area of study: Science related discipline

• Prior work experience in a cleanroom, laboratory, other sterile setting is preferred.

• Prior experience with gowning or related PPE procedures in a sterile environment is preferred.

• Working experience in manufacturing; cGMP setting preferred, and/or some experience as an Associate Level I in bio-pharma industry.

• Able to follow documentation procedures for day to day tasks in a regulated industry

• Proven logic and decision making abilities, critical thinking skills.

• Strong 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.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements 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.