Operator II, Drug Substance - Downstream

Novo Nordisk

Bloomington, IN

Estimated pay: Est. $19–$29/hr (market estimate, not employer-stated)

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance – effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 14 weeks paid parental 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Executes drug substance manufacturing operations with a high degree of independence, performing process steps, monitoring equipment, and troubleshooting routine issues in compliance with GMP, safety and quality requirements, to ensure reliable and consistent production of high-quality product. This role works nights; 6PM - 6:30AM (rotating 3,2,2) Relationships Reports to Manager or above. Essential Functions Preparation Must pass eye exam for all positions within DS This position is a mid-level position in the Preparation Manufacturing team and is the starting point to acquiring skills and training required for a cGMP biomanufacturing environment. The Manufacturing Operator is responsible for the integrity testing, washing, sterilization, and preparation of GMP equipment (stainless steel clamps, J-tubes, scissors, gas filters, valves, etc). using a parts washer, decontamination and sterilization autoclaves, pre- and post-use filter integrity testers, and several other common hand tools (Crimpers, Pliers, tubing cutters, etc.) Follows detailed Batch Records and procedures to prepare and test drug substance equipment and consumables Practices aseptic behaviour within in a clean room environment Safely and accurately loads and operates large machines such as parts washers and autoclaves per procedure Proficient at all GMP activities pertinent to respective area of discipline Capable of leading basic area-specific processing tasks and drives tactical preparations and batch closure tasks Provides basic on-call support for alarm management, as necessary Trains junior team members in basic biomanufacturing processing activities Raises atypical observations and notifies management/quality as required Completes routine and basic preventative maintenance of equipment Performs equipment/room cleanings as required Identifies and raise opportunities for procedural improvements. Supports continuous improvement initiatives Operate in a clean room environment within required gowning, aseptic behaviours, and proper flow procedures Performs general cleanroom housekeeping, including room and equipment cleaning(s), disposal of trash and recyclables, and adherence to 5S standards Assists in stocking and staging production suites Addresses corrections to all executed documentation in a timely manner to support lot release Works scheduled shift and other off-shift coverage as required Executes other duties as assigned Ability to read and write English Perform basic math skills (+, -, x, /, %, understand decimals) Required to read, understand, and follow GMP documents Has basic knowledge of the principles and concepts of a discipline (e.g., Biology, Chemistry) Works independently on limited scope issues Sanitization This position is a mid-level position in the Sanitization Manufacturing team and is the starting point to acquiring skills and training required for a cGMP biomanufacturing environment. The Manufacturing Operator is responsible for the performing scheduled and unscheduled cleanings of the Drug Substance clean rooms, formulation of the approved sanitizing solution, as well as the restock of consumables and gowning materials Follows procedures and schedules in accordance with the site’s Environmental Monitoring strategy to ensure compliance regarding cleanliness of Drug Substance clean rooms Safely and effectively mops cleanroom, floors, walls, and ceilings Formulate sanitizing solutions using detailed procedures, floor scales, and conicals Capable of leading basic area-specific processing tasks and drives tactical preparations Performs daily review of e