Fill Finish Expert

Work set-up: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

Bachelor’s degree in engineering, microbiology, biochemistry, or related life sciences. An advanced degree is preferred., Minimum of 5 years of GMP fill-finish operations experience, with at least 2 years in cell and gene therapy or advanced biologics., Proven expertise in aseptic processing, container closure, visual inspection, and product packaging within regulated environments., Strong knowledge of cleanroom operations, environmental monitoring, and contamination control..

Key responsibilities:

  • Serve as the on-site expert for fill-finish operations supporting GMP manufacturing.
  • Oversee aseptic filling, visual inspection, labeling, and packaging processes.
  • Collaborate with quality, engineering, and validation teams to ensure compliance and efficiency.
  • Support investigations, deviations, and facility readiness activities.

MEDVACON LIFE SCIENCES, LLC logo
MEDVACON LIFE SCIENCES, LLC Pharmaceuticals SME https://www.medvacon.com
51 - 200 Employees
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Job description

This is a six-month contract with no benefits. 

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.

Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Packaging And Labeling
  • Communication

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