Manufacturing Specialist - Aseptic - Fill Finish (Isolator Ops) GOFP

Afton Scientific, LLC • Charlottesville, VA

4d

About The Position

The Manufacturing Specialist - Aseptic - Fill Finish (Isolator Ops) plays a critical role in sterile pharmaceutical manufacturing by operating and maintaining isolator systems for aseptic filling processes. This position ensures compliance with Good Manufacturing Practices (GMP) and supports the production of high-quality injectable drug products in a controlled environment.

Requirements

• At least two (2) years of experience operating isolators in a sterile/aseptic manufacturing facility
• At least two (2) years of experience in a GMP manufacturing facility
• At least one (1) year of experience with routine cleaning, decontamination, and setup of isolators according to SOPs.
• High School Diploma or GED

Nice To Haves

• Experience working with Master Control, and/or SAP.
• Experience with cleanroom operations and environmental monitoring
• Experience with automated filling equipment and troubleshooting isolator
• Previous experience in pharmaceutical or biotech manufacturing
• Exceptional attention to detail and communication skills
• Bachelor’s degree in biology and /or Life Sciences

Responsibilities

• 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
• Participating in training and continuous improvement initiatives
• Maintain a clean and organized work environment in accordance with GMP standards

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED