Ecocareers · 2 months ago
Lead Validation Engineer
WIlson, NC
Full-time
Onsite
Lead/Staff
10+ years expConfidential company is seeking a Lead Validation Engineer who will oversee and drive commissioning and qualification activities for automation and process systems. This leadership role involves ensuring validation strategies align with regulatory expectations and mentoring a team of validation professionals.
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
Required
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
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase