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Katalyst CRO • Wilson, North Carolina, United States
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 expecta
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.
Roles & 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.
Education & Experience
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.