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Ecocareers · 1 month ago

Lead Validation Engineer

Wilson, NC

Full-time

Onsite

Lead/Staff

10+ years exp

Confidential company is seeking a Lead Validation Engineer who 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.

Staffing & Recruiting

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

Qualification

C&Q project managementRegulatory complianceValidation tools proficiencyPMP certificationLeadership skillsStakeholder managementLife sciences domainDelta V & MES ValidationCommunication skillsOrganizational skills