Sr. Systems Validation Specialist / Lead Validation Engineer - LVI Associates : Job Details

About the Role: A global leader in the life sciences sector is seeking a Senior Systems Validation Specialist to oversee equipment qualification and system validation efforts within analytical laboratories. This position is ideal for experienced professionals with deep metrology and validation knowledge who are passionate about compliance, innovation, and improving healthcare outcomes in a collaborative environment.Key Responsibilities:

• Lead the planning and execution of validation projects, ensuring alignment with strategic goals and regulatory timelines
• Provide subject matter expertise in metrology, guiding the interpretation of measurement data and application of best practices
• Oversee the maintenance and qualification of analytical equipment in both GMP and non-GMP labs
• Support internal and external audits, contributing to a state of continuous inspection readiness
• Collaborate across scientific, quality, and partner teams to promote operational excellence and regulatory compliance
• Mentor junior scientists and validation specialists, assigning tasks and offering technical guidance
• Ensure documentation of validation and metrology activities meets regulatory and quality standards
• Participate in change control, deviation management, and compliance-driven process improvements
• Stay current on industry standards and proactively identify opportunities to strengthen validation frameworks

What We're Looking For:

• Bachelor's degree with 7+ years or Master's degree with 5+ years of relevant experience
• Extensive hands-on experience with laboratory equipment validation and metrology in GMP-regulated environments
• Demonstrated ability to lead system and equipment validation efforts independently
• Strong understanding of pharmaceutical compliance, including change and deviation management
• Experience supporting audits and maintaining inspection readiness
• Proficiency with computer system validation and software testing for analytical instrumentation
• Excellent technical writing and documentation skills
• Effective communicator across functional teams and organizational levels
• Located in, or willing to work onsite at West Point or North Wales, PA
• PMP certification preferred

Key Traits for Success:

• Organized and detail-oriented, with excellent time management skills
• Proactive and adaptable in dynamic project environments
• Comfortable leading teams and mentoring others
• Critical thinker with strong troubleshooting abilities
• Committed to continuous learning and cross-functional collaboration

Why Join Us?

• Rapidly growing organization with a people-first culture
• Competitive salary with performance-based incentives
• Comprehensive health benefits: medical, dental, vision
• Employer-paid life, short-term, and long-term disability insurance
• 401(k) with employer match
• Health Savings Account (HSA), FSA, and commuter benefits
• Paid time off, holiday pay, and flexible sick time
• Tuition reimbursement and ongoing learning support
• Paid parental leave and bereavement leave
• Employee recognition and referral programs
• Regular team-building and social activities