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

*Bachelors 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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