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Lead Validation Engineer / Architect - Wilson, NC

Lead Validation Engineer / Architect - Wilson, NC

Floga TechnologiesWilson, NC, United States
3 days ago
Job type
  • Full-time
  • Quick Apply
Job description

Role : Lead Validation Engineer / Architect

Location : Wilson, NC Onsite

Duration : Long term

Top 3 Must Have's : Life science Domain, Validation Skills, Delta V & MES Validation

Job Summary :

  • The Lead Validation Engineer will oversee and drive commissioning and qualification (C&Q) activities for automation and process systems at a regulated manufacturing site .
  • This leadership role is responsible for ensuring validation strategies align with regulatory expectations and project goals, while mentoring a team of validation professionals and coordinating with cross-functional stakeholders .

Key Responsibilities :

  • Lead the planning, execution, and documentation of C&Q lifecycle activities (URS, DQ, IQ, OQ, PQ) for automation and process systems .
  • Develop and implement validation strategies in alignment with quality standards and global regulatory requirements
  • Serve as the primary point of contact for validation-related matters across engineering, QA, manufacturing , and automation teams
  • Review and approve validation protocols, reports, and supporting documentation
  • Manage validation timelines, resource allocation, and risk mitigation plans
  • Provide technical leadership and mentorship to validation engineers and contractors
  • Support audits and inspections by presenting validation documentation and processes
  • Ensure compliance with cGMP, FDA, EU, and internal quality standards .

    • Required Skills :

  • Experience with large-scale C&Q projects in regulated environments
  • PMP or equivalent project management certification
  • Prior experience leading validation efforts in greenfield or brownfield project s
  • Bachelor's or Master's degree in Engineering, Life Sciences , or related field.
  • 10+ years of experience in validation within the pharmaceutical or biotech industry.
  • Demonstrated leadership in managing C&Q projects and teams .
  • Deep understanding of regulatory requirements and industry best practices .
  • Proficiency with validation tools such as Kneat, GVault , or equivalent.
  • Strong communication, organizational, and stakeholder management skills.
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    Validation Engineer • Wilson, NC, United States

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