A

Afton Scientific.

cGMP aseptic drug manufacturing and fills

Manufacturing Specialist - Aseptic - Fill Finish (Isolator Ops) - Multiple Teams

Bioprocess & BiomanufacturingUpdated on Nov 14
Full-timeCharlottesville, VA, USA

About the Job

Requirements

  • At least two years of experience operating isolators in a sterile or aseptic manufacturing facility.
  • At least two years of experience in a Good Manufacturing Practices manufacturing facility.
  • At least one year of experience with routine cleaning, decontamination, and setup of isolators according to standard operating procedures.
  • A high school diploma or GED.

Responsibilities

  • Operate isolator systems for aseptic filling of sterile injectable products.
  • Perform routine cleaning, decontamination, and setup of isolators according to standard operating procedures.
  • Handle sterile components and materials in compliance with aseptic techniques.
  • Complete batch records and controlled documentation accurately and on time.
  • 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 Good Manufacturing Practices standards.

Desired Qualifications

  • Experience working with MasterControl and/or SAP.
  • Experience with cleanroom operations and environmental monitoring.
  • Experience with automated filling equipment and troubleshooting isolators.
  • Previous experience in pharmaceutical or biotechnology manufacturing.
  • A bachelor's degree in biology and/or life sciences.

About the Company

Afton Scientific.

cGMP aseptic drug manufacturing and fills

Afton Scientific runs a cGMP aseptic drug manufacturing facility in Charlottesville, VA, offering Grade A/Class 100 automated aseptic filling for 1–100 mL vials and production runs from 100 to 15,000 units. They use a validated clean-room process to fill sterile liquids and also sell Ready-To-Fill cGMP sterile vials for customers who perform their own fills. The company combines full-service aseptic filling with sterile component supply under one brand and maintains FDA/MHRA inspections to ensure compliance. Their goal is to provide safe, compliant, scalable aseptic filling solutions and sterile vials to pharmaceutical and biotech customers worldwide.

Company size
51-200
Company stage
Not listed
Total funding
Not listed
Headquarters
Charlottesville, VA
Founded
1991

Recently Posted Jobs

Explore more opportunities at Afton Scientific.

See more jobs