Production Operation II

Orano Med, LLC.; Brownsburg (IN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Competitive compensation

Health, Dental, and Vision insurance -

401(k) with employer matching

Life insurance

Short- and Long-Term Disability

Generous Paid Time Off

Training and Development opportunities

and more...

Job summary

Orano Med, LLC. seeks a Production Operator II to drive routine production in a new facility, ensuring aseptic processes and regulatory compliance.

The role emphasizes collaboration with QC/QA, writing and reviewing SOPs, and maintaining audit readiness in a fast-paced environment. You will perform cleanroom activities, gowning, routine disinfection, and materials handling while adhering to EHS guidelines and GMP standards.

Qualifications

• Associate's degree or 60 college credit hours with 2+ years GMP/quality or production experience.
• High School Diploma with 3+ years in GMP quality or production.
• Hands-on GMP production of sterile pharmaceuticals 2+ yrs.
• Cleanroom operations: gowning, cleaning, EM, aseptic technique.
• Follow SOPs and detailed documentation (batch records).
• QMS in regulated environments: QA, GDP, SOPs, document control.
• Ability to work in a fast-paced, high-pressure environment with deadlines.
• Attention to detail; meticulous execution.
• Excellent written and verbal English.

Responsibilities

• Improve processes with management to boost efficiency.
• Train team members and lead by example.
• Write and review SOPs.
• Maintain batch records and equipment logs.
• Ensure regulatory compliance and audit readiness.
• Perform routine cleanings of cleanroom suites.
• Support deviations, CAPAs, change controls.
• Collaborate with QC/QA to ensure product quality.

Skills

Strong problem-solving

Prioritize tasks

Excellent written and verbal English

Detail-oriented

Team participation with leadership

Fast-paced, high-pressure adaptation

Education

Associate's degree or 60 college credit hours with 2+ years GMP/quality or production experience

High School Diploma with 3+ years GMP experience

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Database software

Job description

Job Details

Location: Brownsburg (IN)

Type of Employment: Permanent/Regular

Work Schedule: Full time

Remote Work: In office

Desired Starting Date: 30-11-2026

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.

With a solid portfolio of development projects covering a diverse range of biological molecules capable of recognizing and targeting various forms of cancerous tumors, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular addressing needs of patients currently without effective therapeutic solutions among the existing approaches.

Position Summary

The top priority for 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 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 transfer
• 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
  • Train new employees
  • Other tasks as needed

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+ h
• Lift/move 50 lbs repeatedly/routinely

Wear cleanroom PPE

• Wear cleanroom PPE

Work Skills

• Strong problem-solving skills and the ability to prioritize tasks effectively.
• Proficient with word processing, spreadsheet, and database software, and standard business communication tools (e.g., Microsoft Outlook).
• Ability to prioritize and manage a high volume of complex activities with rapidly changing priorities.
• Excellent written and verbal communication skills in English.
• Detail-oriented with the ability to meticulously compare details in multi-page documents while managing urgent customer needs.
• Demonstrated team participation with leadership behaviors is preferred.

Attitude

• Culture: Quality, Team, Service, Problem Solving
• Teachable, accepts feedback; take responsibility with few excuses
• Eager to learn new processes, accept projects, help with tasks
• Character: integrity; honesty; respect authority; obey rules/policies/laws
• Exemplify values of safety, quality, customer service, and problem solving
• Excellent interpersonal skills
• Servant leadership; service attitude
• Make firm decisions in difficult situations
• Seize opportunities to learn, accept a project, help a task
• Identify problems, take initiative, overcome obstacles; strive toward ambitious goals/timelines

Benefits

• 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...

Orano Group

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.

Compliance and Equal Opportunity

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.