Production Operator II

Description 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 Quality/continuous improvement: 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 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. 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 Profil souhaité 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.