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

Afton Scientific, LLC; Charlottesville (VA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Relocation assistance

Sign-On Bonus

Job summary

A leading company in pharmaceutical manufacturing is seeking a Manufacturing Specialist for aseptic filling processes. The role requires expertise in operating isolators and ensuring GMP compliance within the sterile environment. Candidates must have at least two years of isolator operation experience and a High School Diploma or GED. The position offers opportunities for training and career advancement amidst a commitment to quality and safety.

Qualifications

• At least two years of experience operating isolators in a sterile/aseptic manufacturing facility.
• At least two years of experience in a GMP manufacturing facility.
• High School Diploma or GED required.

Responsibilities

• Operate isolator systems for aseptic filling of sterile injectable products.
• Perform routine cleaning, decontamination, and setup of isolators according to SOPs.
• Collaborate with Quality Assurance and Engineering teams to resolve issues.

Skills

Operating isolators

GMP compliance

Attention to detail

Communication skills

Education

High School Diploma or GED

Bachelor’s degree in biology and/or Life Sciences

Tools

Master Control

SAP

Job description

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

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.

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.

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.