Lead Validation Engineer Architect Wilson, NC

Role: Lead Validation Engineer / Architect
Location: Wilson NC Onsite

Duration: Long term




Top 3 Must Haves: 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
• Bachelors or Masters 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.