GMP Production Operator II: Cleanroom & Process Improvement

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

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.