Production Operator II

Orano•Brownsburg, IN

11d•Onsite

About The Position

Orano Med, a subsidiary of Orano USA, conducts research and develops lead-212-based targeted alpha therapies for cancer. The Production Operator II’s top priority is routine production. The role also supports establishing a new facility designed to meet high standards for quantity, speed, and reliability. The operator performs sterile pharmaceutical manufacturing in a cleanroom environment, follows SOPs and aseptic techniques, supports quality and continuous improvement activities, and collaborates with supervisors, management, QC/QA, MS&T, and process engineers. The position also involves training, documentation, equipment support, cleaning and environmental monitoring, and compliance with safety and regulatory requirements. This is a full-time position in Brownsburg, Indiana, and is not compatible with telework.

Requirements

Associate’s degree or equivalent (60 college credit hours) and at least 2 years of relevant experience, or a high school diploma or equivalent and at least 3 years of experience in a quality- or production-related role in a GMP environment.
At least 2 years of hands-on GMP production experience with sterile pharmaceuticals.
Experience with cleanroom operations, including gowning, cleaning, environmental monitoring, and aseptic technique.
Ability to follow detailed SOPs and complete detailed documentation such as batch records.
Experience with QMS in a regulated environment, including QA, GDP, SOPs, document control, and change control.
Ability to take ownership of the manufacturing process and work in a fast-paced, high-pressure environment with tight deadlines.
Strong attention to detail and meticulous execution and documentation.
Dependable and punctual attendance; flexibility for a variable schedule.
Ability to work under direct supervision or independently, with effective time management.
Ability to stand for 6 or more hours and repeatedly or routinely lift or move 50 pounds.
Ability to wear cleanroom PPE.
Strong problem-solving skills and ability to prioritize tasks effectively, including amid a high volume of complex activities and rapidly changing priorities.
Proficiency with word processing, spreadsheet, and database software, and standard business communication tools such as Microsoft Outlook.
Excellent written and verbal communication skills in English.
Ability to meticulously compare details in multi-page documents while managing urgent customer needs.
Demonstrates integrity, honesty, respect for authority, and compliance with rules, policies, and laws; exemplifies safety, quality, customer service, and problem solving.
Ability to accept feedback, take responsibility, learn new processes, and take initiative to address problems and overcome obstacles.

Nice To Haves

Demonstrated team participation with leadership behaviors.

Responsibilities

Prioritize daily routine production and perform manufacturing activities in accordance with SOPs and proper aseptic technique.
Set up production, perform line clearance, and conduct cleaning and VPHP activities.
Troubleshoot urgent problems and identify, document, and communicate failures and near misses.
Work with the management team to improve processes and collaborate with the shift supervisor to support efficient shift operations and lead by example.
Collaborate with the shift supervisor to train team members and train new employees.
Write and review relevant SOPs and help keep the site audit-ready.
Perform routine cleaning and disinfection of cleanroom suites; cross-train in cleanroom cleaning, environmental monitoring, and restocking.
Complete SOP reading, gowning qualification, media fills, process training, bioburden runs, PV runs, and technology transfer activities.
Follow EHS requirements and applicable NRC, OSHA, EPA, chemical, waste-disposal, and state and local regulations.
Adhere to SOPs, company policies, regulatory requirements, and laws; work with QC/QA to deliver quality products.
Assist with deviations, OOT/OOS investigations, CAPAs, change controls, audits, and inspections.
Collaborate with MS&T and process engineers to identify process improvements and help execute development work needed to implement changes.
Conduct routine radiation surveys and wipe tests.
Maintain paper and electronic batch records, equipment logs, and other records.
Maintain, qualify, calibrate, and prepare equipment; report equipment problems and troubleshoot as needed.
Maintain material and supply stock and obtain documentation required for raw material release.
Perform other tasks as needed.