Aseptic Fill-Finish Specialist (Isolator Ops)

Afton Scientific; Charlottesville (VA); Presencial; USD 41.000 - 47.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation assistance

Sign-on bonus

Descripción de la vacante

Afton Scientific in Charlottesville, VA is seeking a Manufacturing Specialist - Aseptic - Fill Finish (Isolator Ops) to operate isolator systems for aseptic filling of sterile injectable products in a GMP-controlled facility. This role supports compliant manufacturing and requires meticulous documentation and teamwork.

The position demands at least two years’ isolator experience in sterile manufacturing plus GMP exposure; a Bachelor’s degree in biology/Life Sciences is preferred.

Formación

• At least two years operating isolators in a sterile/aseptic manufacturing facility.
• At least two years of GMP manufacturing facility experience.
• One year of experience with cleaning, decontamination, and setup of isolators per SOPs.

Responsabilidades

• Operate isolator systems for aseptic filling of sterile injectable products.
• Perform routine cleaning, decontamination, and setup of isolators according to SOPs.
• Handle sterile components and materials in compliance with aseptic techniques.
• Complete batch records and controlled documentation accurately and timely.
• Monitor and document environmental conditions and equipment performance.
• Collaborate with Quality Assurance and Engineering teams to resolve issues and maintain compliance.
• Participate in training and continuous improvement initiatives.
• Maintain a clean and organized work environment in accordance with GMP standards.

Conocimientos

Isolator operation

GMP compliance

Environmental monitoring

Documentation accuracy

Educación

Bachelor's degree in Biology/Life Sciences

Herramientas

Master Control

SAP

Descripción del empleo

Afton Scientific in Charlottesville, VA is seeking a Manufacturing Specialist - Aseptic - Fill Finish (Isolator Ops) to operate isolator systems for aseptic filling of sterile injectable products in a GMP-controlled facility. This role supports compliant manufacturing and requires meticulous documentation and teamwork.

The position demands at least two years’ isolator experience in sterile manufacturing plus GMP exposure; a Bachelor’s degree in biology/Life Sciences is preferred.