Manufacturing Associate Level 3

Lonza•Portsmouth, NH

1d•Onsite

About The Position

Manufacturing Associate III The location of this job is on site in Portsmouth, New Hampshire. The Manufacturing Associate III is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level III associates are expected to be fully proficient in executing process recipes, following written procedures (SOPs), monitoring equipment and processes, independently performing laboratory tasks, including pH, conductivity testing, product sampling, and conducting routine sanitization tasks to maintain facility and equipment and train other operators on these tasks. They are expected to demonstrate a significant knowledge of cGMP compliance and an in-depth understanding of process flow and be able to make decisions based on that experience. Level III Operators are able to troubleshoot routine and non-routine equipment events, initiate deviations, review batch records and logbooks. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.

Requirements

High School Diploma or equivalent.
Ability to wear appropriate PPE required.
Proven logic and decision-making abilities, critical thinking skills
Strong written and verbal communication skills required

Nice To Haves

Bachelor’s Degree preferred
5+ years GMP manufacturing experience preferred.

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), troubleshooting issues and review documentation as appropriate.
Demonstrate proficiency and understanding of suite specific production activities and laboratory tasks such as bioreactor inoculation, chromatography column operation, product sampling, etc. and the scientific theory behind the operations. May train other associates on these tasks and theory.
Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects, technical writing (deviations, document change forms, etc.).
Attain qualification for all assigned tasks and maintain individual training plan
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.
Perform other duties as assigned.