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

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

About The Job

At Afton Scientific, every role contributes to advancing the quality and reliability of sterile pharmaceutical manufacturing. Our team is driven by innovation, collaboration, and a commitment to excellence. We support employees at every stage of their career by fostering an environment where development, learning, and meaningful impact are possible.

About The Job

We invite you to explore opportunities to join our organization and contribute to our mission. We are currently seeking a Manufacturing Specialist - Aseptic - Fill Finish (Isolator Ops) to support our growing biopharmaceutical operations at our on-site facility in Charlottesville, Virginia. (Relocation + Sign On Bonus )

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.

Pay Details: Non-exempt position, range of $30 - $34 per hour, depending on level of experience.

Non-Negotiable 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

Preferred Requirements

• 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 Include

• 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

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. This role may require sitting, standing, or walking for extended periods; using a computer; and working in a standard office environment. Specific physical or environmental requirements will be addressed through the reasonable accommodation process. We do not discriminate based on disability and will provide reasonable accommodation as required by law.