Qualification & Validation Subject Matter Expert (SME)

In this highly visible role, you'll partner with Quality, Engineering, Manufacturing, Validation, Technical Services, Automation, and site leadership teams to strengthen validation programs, address complex compliance challenges, drive continuous improvement, and support operational excellence across multiple manufacturing locations.

What You'll Be Doing

• Provide technical leadership and subject matter expertise for qualification and validation programs across manufacturing operations.
• Support regulatory inspection readiness activities and serve as a validation expert during health authority inspections, regulatory interactions, and response efforts.
• Contribute to remediation plans and regulatory responses associated with observations, Warning Letters, regulatory commitments, and significant validation findings.
• Assess and strengthen lifecycle management programs for facilities, utilities, equipment, manufacturing processes, cleaning processes, computerized systems, laboratory systems, and sterilization processes.
• Lead risk-based assessments of validation programs to identify compliance gaps, technical risks, and improvement opportunities.
• Review and provide guidance on deviations, investigations, change controls, qualification packages, validation protocols, reports, and CAPAs related to validation activities.
• Support remediation initiatives to address historical validation deficiencies, compliance gaps, and regulatory commitments.
• Ensure validation strategies are scientifically sound, risk-based, appropriately documented, and aligned with current regulatory expectations and industry best practices.
• Provide technical leadership for qualification of manufacturing equipment, clean utilities, facilities, HVAC systems, water systems, environmental control systems, and supporting infrastructure.
• Support process validation, cleaning validation, sterilization validation, and computerized systems validation/computer software assurance programs.
• Partner with Engineering, Manufacturing Science & Technology, Quality, Automation, Technical Services, and site leadership to improve validation effectiveness and compliance performance.
• Conduct site assessments, gap analyses, compliance reviews, and mock inspections focused on qualification and validation systems.
• Monitor validation program performance, identify recurring trends and systemic issues, and recommend actions to strengthen compliance.
• Drive standardization and harmonization of validation methodologies, risk assessment approaches, and qualification practices across sites.
• Coach and mentor validation, engineering, and quality teams on regulatory expectations and validation best practices.

What You'll Bring

• Bachelor's degree in Engineering, Pharmacy, Chemistry, Biological Sciences, or Life Sciences required; advanced degree preferred.
• 15+ years of experience in pharmaceutical manufacturing validation, engineering, technical services, quality, or other technical functions within regulated manufacturing environments.
• Significant experience supporting qualification and validation programs in GMP-regulated pharmaceutical manufacturing.
• Strong expertise in equipment qualification (IQ/OQ/PQ), facility and utility qualification, HVAC qualification, water system validation, process validation, cleaning validation, sterilization validation, computerized systems validation (CSV), computer software assurance (CSA), lifecycle validation management, and quality risk management.
• Deep understanding of validation lifecycle principles, data integrity requirements, and current global regulatory expectations related to qualification and validation programs.
• Demonstrated experience supporting regulatory inspections, regulatory responses, and remediation programs involving validation and qualification systems.
• Proven ability to evaluate complex technical issues, interpret regulatory requirements, and provide sound, risk-based recommendations.
• Strong investigation, root cause analysis, CAPA development, and effectiveness verification skills.
• Excellent communication, coaching, and influencing skills with the ability to effectively partner with site leadership and cross-functional technical teams.
• Experience leading or supporting large-scale remediation and compliance improvement initiatives preferred.
• Experience in sterile pharmaceutical manufacturing, injectable products, IV solutions, aseptic processing, or combination products preferred.
• Ability to travel regularly and maintain a strong on-site presence across supported manufacturing locations.