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

Posted 13 Days Ago
Be an Early Applicant
Charlottesville, VA, USA
In-Office
30-34 Hourly
Junior
Pharmaceutical • Manufacturing
The Role
Operates and maintains isolator systems for aseptic filling of sterile injectable products. Performs cleaning, decontamination, setup, component handling, batch documentation, environmental monitoring, and equipment performance checks under GMP standards. Collaborates with Quality Assurance and Engineering to resolve issues, maintain compliance, complete training, and support continuous improvement in a controlled pharmaceutical manufacturing environment.
Summary Generated by Built In
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.

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 )


Overview of this 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.


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.

Skills Required

  • At least two years of experience operating isolators in a sterile or aseptic manufacturing facility
  • At least two years of experience in a GMP manufacturing facility
  • At least one year of experience with routine cleaning, decontamination, and setup of isolators according to SOPs
  • High school diploma or GED
  • Experience with MasterControl and/or SAP
  • Experience with cleanroom operations and environmental monitoring
  • Experience with automated filling equipment and isolator troubleshooting
  • Previous experience in pharmaceutical or biotech manufacturing
  • Exceptional attention to detail and communication skills
  • Bachelor's degree in biology and/or life sciences
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The Company
HQ: Charlottesville, VA
79 Employees
Year Founded: 1991

What We Do

Afton Scientific is a Virginia-based contract development and manufacturing organization (CDMO) specializing in small-batch sterile injectable filling from clinical trials through approved commercial drugs. It provides aseptic manufacturing, fill-finish, packaging and labeling, analytical and microbiology laboratory services, pharmaceutical support, and pre-sterilized Ready-To-Fill components. The company serves pharmaceutical clients internationally and supports regulated pharmaceutical products and therapies.

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