6068 - Cell & Gene Therapy SME / Lead Process Engineer

Verista, Inc.(1 month ago)

HybridFull TimeSenior$85,000 - $150,000Process Engineering

About this role

The Cell & Gene Therapy SME / Lead Process Engineer serves as the subject matter expert for process validation and regulatory compliance in cell and gene therapy manufacturing. The role focuses on ensuring processes meet global regulatory standards and are validated for consistency, safety, and efficacy. The position supports cross-functional teams, technology transfer, and regulatory alignment across the product lifecycle.

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Required Skills

Process Validation
Equipment Qualification
Cleaning Validation
Analytical Methods
IQ/OQ/PQ
Regulatory Compliance
Regulatory Submissions
cGMP
cGTP
Audit Readiness

+7 more

Qualifications

Bachelor's or Master's in Biotechnology or Pharmaceutical Sciences

About Verista, Inc.

verista.com

Verista is a life‑sciences consulting and engineering firm that supports pharmaceutical, biotech, medical device, and consumer‑health companies across the entire product lifecycle. They specialize in validation, quality and regulatory compliance, engineering and automation, commissioning/qualification, computer system validation, and digital transformation. Verista combines domain‑specific technical expertise and regulatory know‑how with hands‑on implementation to reduce risk, accelerate timelines, and ensure GxP compliance for complex manufacturing, clinical, and commercial operations.