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

Afton Scientific. LLC; Charlottesville (VA); Vor Ort; USD 60.000 - 80.000; Vollzeit

Zusammenfassung

A prominent biopharmaceutical company in Charlottesville, Virginia, is seeking a Manufacturing Specialist - Aseptic - Fill Finish to manage isolator systems in sterile pharmaceutical manufacturing. This role includes ensuring GMP compliance, performing routine cleaning and setup of isolators, and documenting environmental conditions. Candidates should have at least two years of experience in sterile manufacturing and possess strong attention to detail and communication skills. A relocation and sign-on bonus are available.

Qualifikationen

• 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.
• Experience with routine cleaning, decontamination, and setup of isolators.

Aufgaben

• 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.

Kenntnisse

Operating isolators

GMP compliance

Attention to detail

Communication skills

Ausbildung

High School Diploma or GED

Bachelor's degree in biology and/or Life Sciences

Tools

Master Control

SAP

Jobbeschreibung

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.

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.