Production Operator II

Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the extraction and purification of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative Pb-212-based treatments which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. The top priority for the Production Operator II will be routine production. This position presents the opportunity to help establish a new facility that will meet high standards for quantity, speed, and reliability. A competitive candidate will be energetic and motivated. Key Responsibilities Work with Production Supervisor and Management team to improve the process Collaborate with the shift supervisor to ensure the shift is running efficiently while leading by example Collaborate with the shift supervisor to train other members of the team Writing and reviewing relevant SOPs Help ensure the site is in an audit ready state Perform routine cleaning/disinfection of the cleanroom suites Complete: reading SOPs, gowning qualification, media fills, process training, bioburden runs, PV runs, tech transf Top priority: Daily routine production Follow EHS regulations/guidelines: NRC (ALARA), OSHA, EPA, chemical, waste disposal, state/local regulations, etc. Manufacturing activities following SOPs, using proper aseptic technique Setup production; line clearance; clean/VPHP Troubleshoot urgent problems Identify, document, communicate failures/near misses Adhere to SOPs, company policies, regulatory requirements, laws Work closely with QC/QA to deliver quality products Assist with deviations, OOT/OOS, CAPAs, change controls, audits, inspections Collaborate with MS&T and process engineers to identify process improvements and help execute development work needed to implement change Cross-train and perform: Cleanrooms: cleaning, EM, restocking Routine radiation surveys, wipe tests Other: Maintain paper/electronic batch records, equipment logs, other records Equipment: maintain, qualify, calibrate, prepare, report problems, troubleshooting Maintain stock of materials/supplies; obtain documentation for raw material release Mentor new employees Train new employees Other tasks as needed Orano strives to provide a total compensation package that brings value to our employees. We also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification from upon hire. This position requires a pre-employment background check and drug screening. Orano is an Equal Opportunity Employer. Orano and all subsidiaries abide by applicable legal requirements. We ensure that all personnel actions such as recruitment, compensation, career development, benefits, and company-sponsored training are administered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, protected veteran, or other protected status. Requirements Qualifications Education Associate’s degree or equivalent (60 college credit hours) with 2+ years of relevant experience, or High School Diploma (or equivalent) with 3 or more years of experience in a quality or production-related role within a GMP environment. Experience Hands-on GMP production of sterile pharmaceuticals 2+ yrs Cleanroom operations: gowning, cleaning, EM, aseptic technique Follow detailed SOPs, complete detailed documentation (e.g., batch records) QMS in a regulated environment: QA, GDP, SOPs, document control, change control Owns the manufacturing process; work well in a fast-paced, high-pressure environment with tight deadlines Attention to detail; meticulous execution/documentation Attendance: dependable, on time; flexible for variable schedule Work well under direct supervision or independently Time management Stand for 6+ hours Lift/move 50 lbs repeatedly/routinely Wear cleanroom PPE All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position. Competitive compensation Health, Dental, and Vision insurance – with generous employer contributions 401(k) with employer matching and contribution amounts Life insurance and Short- and Long-Term Disability insurance provided by the company Generous Paid Time Off and holiday schedules Numerous Training and Development opportunities and more… Present in the United States for 60 years, Orano USA is a leading technology and services provider to the U.S. commercial and federal markets. Orano’s activities in the U.S. include developing uranium enrichment facility in Oak Ridge, TN ; packages and transportation of uranium & nuclear fuel assemblies ; fabricating & installing used nuclear fuel dry storage canisters and casks, conducting pool-to-pad used nuclear fuel transfers ; providing solutions to the National Labs and to the Dept of Energy ; and supplying U.S. nuclear energy utilities with uranium, conversion, and enrichment services. In the nuclear medicine field, Orano Med is at the forefront of research in nuclear medicine and is developing a new generation of targeted therapies against cancer using the unique properties of lead-212. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. This position requires a pre-employment background check and drug screening. Orano is an Equal Opportunity Employer. Orano and all subsidiaries abide by applicable legal requirements. We ensure that all personnel actions such as recruitment, compensation, career development, benefits, and company-sponsored training are administered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, protected veteran, or other protected status. #J-18808-Ljbffr Orano Projects Limited