Fill Finish Expert
a day ago
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RemoteFull-timeSenior
Summary
MEDVACON LIFE SCIENCES, LLC is seeking a Fill Finish Expert to support operations within a GMP-regulated cell and gene therapy manufacturing environment in Boston, MA. The role involves technical leadership and on-site execution in aseptic filling, visual inspection, labeling, and packaging.
About the Role
As a Fill Finish Expert, you will serve as the on-site subject matter expert for fill-finish operations, overseeing aseptic filling processes, supporting visual inspection and packaging operations, and collaborating with cross-functional teams to ensure compliance and optimize performance. You will also lead investigations related to fill-finish operations, assess facility readiness, and train operations staff on aseptic behavior and cleanroom discipline.
About You
Required:
- Bachelor’s degree in engineering, microbiology, biochemistry, or a related life sciences discipline.
- A minimum of 5 years of experience in GMP fill-finish operations, with at least 2 years supporting cell and gene therapy or other advanced biologic products.
- Proven experience supporting aseptic processing, container closure systems, visual inspection, and product packaging in regulated environments.
- Strong working knowledge of cleanroom operations, environmental monitoring, and contamination control.
- Excellent communication, technical writing, and cross-functional collaboration skills.
Preferred:
- An advanced degree in a relevant field.
- Familiarity with FDA, EMA, USP, and ICH guidelines related to sterile product manufacturing.
- Experience supporting equipment qualification, media simulations, and sterile process validation.
- Endotoxin control experience.
Benefits
- This is a six-month contract with no benefits.
MEDVACON LIFE SCIENCES, LLC
MEDVACON is a globally recognized company offering tailored FDA Quality Compliance and Technical Consulting Services. We partner with Life Sciences Companies to achieve optimal solutions while managing compliance costs effectively. MEDVACON’s extensive array of services include, Validation, Qualification, Quality Systems, IT Computer System Validation/Software Quality Assurance (CSV/SQA), FDA Audit Preparation, Response and Remediation Services, Training, Tech Transfers, and Project Management. We look forward to partnering with you!
Boston, MA