Production Operator II

Orano Projects Limited; Brownsburg, Northern (IN, KY); Hybrid; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health, Dental, Vision insurance

401(k) with employer matching

Life Insurance & Disability

Paid Time Off

Training & Development

Job summary

Orano Med, a leader in nuclear medicine research, seeks a Production Operator II to support routine GMP production in a new facility. You will work with Supervisors, train team members, and help ensure an audit-ready site while following SOPs and safety guidelines.

The role requires hands-on manufacturing of sterile products, cleanroom discipline, and strong documentation. A 60-year U.S. presence and comprehensive benefits accompany this opportunity.

Qualifications

• Hands-on GMP production of sterile pharmaceuticals.
• Experience in cleanroom operations and gowning.
• Ability to follow detailed SOPs and documentation.

Responsibilities

• Collaborate with Production Supervisor and Management to improve the process.
• Lead by example and train other team members on shift.
• Write and review SOPs; ensure audit readiness.
• Perform routine cleaning/disinfection of cleanrooms.
• Complete batch records and quality-related documentation.
• Support deviations, OOT/OOS, CAPAs and change controls.
• Work with MS&T and process engineers on improvements.

Skills

GMP Production

Cleanroom Operations

SOPs & Documentation

QA/QC Awareness

Time Management

Attention to Detail

Education

Associate degree or equivalent (60 college credit hours) with 2+ years GMP experience

High School Diploma with 3+ years GMP experience

Job 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
• 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.