Andrew Herman
Validation Engineer Ii @Quality Agents, Llc
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WORK HISTORY
Validation Engineer Ii @Quality Agents, Llc
Supported validation of the CliniMACS Prodigy T-Cell processing system, contributing to execution and documentation for automated cell therapy manufacturing workflows. Lead technical documentation development and review including URS, risk assessments, validation protocols, and summary reports. Support deviation investigations, root cause analysis, and implementation of corrective and preventative actions (CAPAs). Review and revise SOPs, batch records, and technical documents to ensure alignment with manufacturing processes. Interface with quality systems (Maximo, BMRAM, Veeva) to manage documentation, change controls, and equipment lifecycle records. Collaborate with manufacturing teams to assess process changes and product impact through structured risk analysis.
EDUCATION
University of Maryland
Bachelors, Pre-Medicine/Pre-Medical Studies
University of Maryland Global Campus
Masters, Business Administration and Management, General
ABOUT ANDREW HERMAN
As a Validation Engineer and GMP manufacturing professional, I’ve supported cell and gene therapy operations through manufacturing investigations, technical documentation, and cross-functional collaboration with Quality, Manufacturing, and Engineering to resolve deviations, implement CAPAs, and sustain GMP compliance. My experience includes stakeholder management, CAR‑T R&D and manufacturing, CliniMACS Prodigy and Sefia validation, and validation engineering leadership within regulated biotech environments.I hold an MBA and PMP certification, enabling me to translate complex technical needs into structured project plans, clear governance, and measurable outcomes. My goal is to step into a Project Manager role in cell therapy, combining risk-based validation, change control, and resource/schedule management to deliver compliant, scalable therapies that reach patients faster.
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