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

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.

• 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

•High School Diploma or GED

• 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

•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.