Lead Validation Engineer

Job Responsibilities

• Lead cross-functional validation activities for facility, utility, equipment, analytical, computerized systems, cleaning, and process validation programs.
• Develop, implement, and continuously improve commissioning, qualification, and validation strategies for GMP and non-GMP spaces including office, warehouse, development, quality control, sterility/microbiology, and production areas.
• Partner with project teams, consultants, contractors, Quality, Engineering, QC, and Operations to deliver validation milestones aligned with business and compliance objectives.
• Provide technical leadership for day-to-day development and GMP manufacturing support, including troubleshooting, risk assessments, and validation impact assessments.
• Own and manage complex validation programs and ensure timely execution of protocols, reports, and lifecycle documentation.
• Review and approve validation documents including SOPs, forms, protocols, technical reports, deviations, CAPAs, change controls, and summary reports.
• Lead deviation investigations and support root cause analysis, corrective actions, and preventive actions related to validation and manufacturing systems.
• Drive continuous improvement projects that enhance compliance, efficiency, and operational readiness.
• Mentor, coach, and develop validation engineers and cross-functional team members.
• Support regulatory inspections and internal audits by presenting validation strategies, rationale, and supporting documentation.
• Track and communicate departmental KPIs, project status, risks, and resource needs to leadership.
• Support onboarding of new technologies, facility modifications, and expansion projects as required.

Education And Experience

• BS or MS in a scientific or engineering discipline, or equivalent work experience.
• 5+ years of experience in a radiopharmaceutical, injectable, or other regulated GMP manufacturing environment.
• 5+ years of validation experience within a GMP-regulated environment.
• Demonstrated experience leading complex validation programs and cross-functional initiatives.
• Prior experience mentoring engineers or leading project workstreams is strongly preferred.

Skills And Qualifications

• Strong technical writing and document review skills.
• Deep understanding of regulatory expectations for validation, lifecycle management, and risk management.
• Strong leadership, decision-making, and problem-solving skills.
• Ability to work independently while effectively influencing cross-functional teams.
• Excellent communication, organization, and project management capabilities.
• Prioritizing multiple initiatives in a fast-paced GMP environment.
• Broad validation knowledge across areas such as process validation, cleaning validation, computer system validation, equipment qualification, and QC assets.
• High level of professional ethics, integrity, and ability to maintain confidential information.
• Applies AI to improve team execution and decision-making.