Lead Validation Engineer

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.