Sr. Systems Validation Specialist / Lead Validation Engineer
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
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