Fill Finish Expert

We are seeking an experienced Fill-Finish Expert to support operations within a GMP-regulated cell and gene therapy manufacturing environment. This role requires both technical leadership and on-site execution, with direct involvement in aseptic filling, visual inspection, labeling, packaging, and related support systems. The ideal candidate will work closely with cross-functional teams across manufacturing, quality, and engineering to ensure compliance, optimize performance, and troubleshoot operational issues. Experience in endotoxin control and contamination prevention is a plus.

Responsibilities

*Serve as the on-site subject matter expert for fill-finish operations supporting CGT production in a GMP environment

*Oversee aseptic filling processes including manual and automated operations, equipment setup, sterilization, filtration, and integration with upstream and downstream steps

*Support visual inspection, labeling, and packaging operations, including material and container closure integrity control

*Work collaboratively with quality, engineering, MSAT, and validation teams to ensure compliant and efficient execution of fill-finish activities

*Lead or support investigations, CAPAs, and deviation management related to fill-finish operations and cleanroom performance

*Assess and support facility readiness, including line qualification, media fills, environmental monitoring, and EM excursions

*Author and review batch records, protocols, SOPs, training documents, and technical reports in accordance with current regulatory expectations

*Train operations staff on aseptic behavior, gowning, filling techniques, and cleanroom discipline

*Contribute to inspection readiness and participate in audits related to sterile manufacturing and fill-finish activities

Qualifications

*Bachelor’s degree in engineering, microbiology, biochemistry, or a related life sciences discipline. An advanced degree is preferred

*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

*Familiarity with FDA, EMA, USP, and ICH guidelines related to sterile product manufacturing, container closure integrity, and visual inspection

*Experience supporting equipment qualification, media simulations, and sterile process validation

*Excellent communication, technical writing, and cross-functional collaboration skills

*Endotoxin control experience is a plus but not required

*Ability to work independently on-site and contribute as a trusted technical resource in a fast-paced, team-oriented environment

This is a remote position that requires some on-site presence in Massachusetts.

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