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Lead Validation Engineer

Non-Headquarters

Valpro has several available opportunities supporting our world-class client sites or partner organizations.  Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below.

Lead Validation Engineer

Location: Raleigh-Durham, NC

Position Summary:

The CSV Lead is responsible for overseeing and or maintaining computer system validation. This role ensures that all systems are designed, tested, and documented in alignment with project requirements and safety standards.

Responsibilities:

 

  • Lead computer system validation (CSV) efforts across a range of system types and platforms.
  • Provide technical oversight for automation, enterprise, infrastructure, manufacturing execution, and laboratory computer systems.
  • Interpret and apply internal validation policies and procedures to ensure compliant system delivery.
  • Collaborate with commissioning, qualification, and quality teams to define validation strategies and develop system-specific plans.
  • Review and evaluate vendor documentation, including requirements, test plans, design specifications, acceptance testing, and risk assessments.
  • Facilitate and document system design reviews to ensure alignment with regulatory and quality expectations.
  • Develop, update, and execute validation and testing protocols as required.
  • Track and maintain all validation documentation and deliverables throughout the project lifecycle.
  • Support data integrity assessments and ensure compliance with applicable standards.
  • Contribute to change management activities, ensuring modifications follow established engineering and quality processes.
  • Assess and document changes to previously validated systems.
  • Provide scheduling input and resource planning related to CSV activities.
  • Assist in defining vendor scope and validation deliverables within statements of work.
  • Coordinate and perform validation execution activities as needed. Prepare and review final reports summarizing validation activities and compliance results.

Skills:

 

  • 10+ years of Computer System Validation (CSV) experience with MES and data integration systems (Emerson DeltaV, Syncade / Rockwell PLC, PlantPAx, PMX / Siemens S7, Opcenter Execution Pharma /and/or Honeywell Experion, OSI PI experience is highly preferred)
  • Experience with the commissioning and qualification of automation and related systems within virtual and production cGMP environments.
  • Direct experience developing validation protocols and execution of protocols.
  • Experience creating validation master plans and performing risk assessments.
  • Passionate about leading and mentoring others.
  • Tactical thinker with experience working with customers developing testing, validation and/or quality strategies.
  • Excellent client communication skills.

Education:

  • Minimum of 10 years of role-specific experience.

 

Join a great team supporting top notch clients. Apply Today!

 

 

Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives.

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