MES Validation Engineer

4 days ago


Durham, North Carolina, United States Valspec Full time
Job Overview

Valspec, a global leader in system validation and lifecycle services, is seeking a highly skilled MES Validation Engineer to join our team. As a key member of our team, you will be responsible for ensuring the validation and qualification of computerized systems for our clients in the Life Sciences industry.

About Valspec

Valspec is a trusted partner for clients in the Life Sciences industry, providing commissioning and qualification of computerized systems. Our mission is to provide a wide spectrum of services that help our clients meet their capital project and lifecycle maintenance goals.

Responsibilities

  • Support the execution of small projects or portions of larger projects.
  • Develop and execute qualification protocols and final summary reports.
  • Conduct risk assessments and participate in Quality/Regulatory audits.
  • Support the generation of quality assurance plans, verification plans, and validation plans.

Requirements

  • 3+ years of Computer System Validation (CSV) experience with process control, SCADA, and automation systems.
  • Manufacturing Execution System (MES) experience.
  • Experience with automation, commissioning, qualification, or operations in a cGMP environment.
  • Direct experience developing validation protocols and executing protocols.
  • Knowledge of current industry standards such as GAMP5 and ASTM E2500.

Preferred Skills

  • Exposure to Kneat or ValGenesis.

What We Offer

Valspec offers a competitive benefits package, including premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives. We are an Equal Opportunity Employer and welcome applications from qualified candidates.


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