Aseptic Fill-Finish Specialist (Isolator Ops) - Relocation

BioSpace; Charlottesville (VA); On-site; USD 41,000 - 47,000; Full time

Job summary

Afton Scientific in Charlottesville, VA is seeking a Manufacturing Specialist - Aseptic - Fill Finish (Isolator Ops) to operate and maintain isolator systems for aseptic filling of sterile injectables. This role ensures GMP compliance and accurate batch records in a controlled environment.

Responsibilities include cleaning, decontamination, setup of isolators per SOPs, documentation, environmental monitoring, and collaboration with QA and Engineering to resolve issues.

Qualifications

• Two or more years operating isolators in a sterile/aseptic manufacturing facility.
• Two or more years in a GMP manufacturing facility.
• At least one year of isolator cleaning, decontamination, and setup per SOPs.
• HS diploma or GED required.

Responsibilities

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

Skills

Isolator operations

GMP manufacturing

SOP compliance

Attention to detail

Education

High School Diploma or GED

Bachelor’s degree in biology/Life Sciences

Tools

MasterControl

SAP

Automated filling equipment

Environmental monitoring

Job description

Afton Scientific in Charlottesville, VA is seeking a Manufacturing Specialist - Aseptic - Fill Finish (Isolator Ops) to operate and maintain isolator systems for aseptic filling of sterile injectables. This role ensures GMP compliance and accurate batch records in a controlled environment.

Responsibilities include cleaning, decontamination, setup of isolators per SOPs, documentation, environmental monitoring, and collaboration with QA and Engineering to resolve issues.