Production Operation II

Orano; Brownsburg (IN); Presencial; USD 45.000 - 70.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation

Health, Dental, and Vision insurance

401(k) with employer matching

Life insurance

Paid Time Off

Training and Development opportunities

and more…

Descripción de la vacante

Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing Pb-212-based therapies.

The Production Operator II role focuses on daily routine GMP production in a new facility, with opportunities to contribute to process improvements and audit readiness. The ideal candidate is energetic, dependable, and able to work in a fast-paced environment.

Formación

• Hands-on GMP production of sterile pharmaceuticals.
• Follow detailed SOPs and complete detailed documentation (batch records).
• QMS in a regulated environment: QA, GDP, SOPs, document control, change control.
• Owns the manufacturing process; works well in a fast-paced, high-pressure environment.
• Attendance: dependable and on time; flexible for variable schedule.
• Stand for 6+ hours and lift/move up to 50 lbs; wear cleanroom PPE.

Responsabilidades

• Work with management to improve the process and efficiency.
• Collaborate with the shift supervisor to run and train the team; lead by example.
• Write and review SOPs; maintain batch records and logs.
• Maintain audit readiness, prepare for inspections and deviations handling.
• Perform routine cleaning and bioburden checks in cleanrooms; support tech transfer.

Conocimientos

GMP production

Sterile pharmaceuticals

SOP compliance

Documentation

QA collaboration

Cleanroom PPE

Educación

Associate degree or 60 college credits with 2+ yrs experience

High School diploma with 3+ yrs GMP experience

Descripción del empleo

Métier N - LABORATOIRE

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
• 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
• 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

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.
• Culture: Quality, Team, Service, Problem Solving
• Teachable, accepts feedback; t ake 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
• M ake firm decisions in difficult situations
• Seize opportunities to learn, accept a project, help with a task
• Identify problems, take initiative, overcome obstacles; strive toward ambitious goals/timelines

Avantages

• 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…

Groupe Orano

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.