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Jobs via Dice • Wilson, North Carolina, United States
Role & seniority: Lead Validation Engineer (senior/lead level)
Location & work type: Wilson, NC, onsite; Contract role
Stack/tools: Validation platforms (Kneat, GVault or equivalent); CSV; MES; PCS (Process Control System); Emerson Delta V; cGMP/FDA/EU regulatory standards
Lead planning, execution, and documentation of C&Q lifecycle (URS, DQ, IQ, OQ, PQ) for automation and process systems
Develop and implement validation strategies aligned with quality standards and regulatory requirements; mentor validation staff
Serve as primary validation interface across engineering, QA, manufacturing, and automation; review/approve protocols and reports; manage timelines, resources, and risk; support audits
10+ years in validation within pharmaceutical/biotech; strong leadership in C&Q projects and teams
Deep regulatory knowledge (cGMP, FDA, EU) and industry best practices
Proficiency with Kneat, GVault (or equivalent); strong communication, organizational, and stakeholder-management skills
PMP or equivalent project management certification
Experience leading large-scale C&Q in greenfield or brownfield projects
Note: Candidate must be able to work onsite in Wilson, NC; contract role.
Dice is the leading career destination for tech experts at every stage of their careers. Our client, Digitive LLC, is seeking the following. Apply via Dice today!
Lead Validation Engineer
Wilson, NC - onsite
Contract
Top 3 Must Have's: Life science Domain, Validation Skills, Delta V & MES Validation
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.
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.
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.
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 projects.
Years of Experience: 16.00 Years of Experience
Validation
CSV
MES
PCS (Process Control System)
Emerson Delta V