Senior Validation Engineer

Responsibilities

• Lead development and execution of validation strategies for equipment, utility, process, cleaning, and computer system validation (CSV) programs
• Author and approve Installation/Operational/Performance Qualification (IQ/OQ/PQ) protocols and reports for complex or high-risk systems
• Own CSV lifecycle activities for GxP systems, ensuring compliance with 21 CFR Part 11, GAMP 5, and (where applicable) risk-based CSA methodologies
• Lead process validation and Process Performance Qualification (PPQ) studies for new products, process changes, and technology transfers
• Serve as validation subject matter expert (SME) during internal audits and external regulatory inspections (FDA, ISO), including front room/back room support
• Develop and maintain Validation Master Plans, risk assessments, and site validation policies/SOPs
• Lead root cause investigations and CAPAs related to validation failures, deviations, and revalidation triggers
• Review and approve change controls requiring revalidation assessments, ensuring appropriate scope and risk-based justification
• Mentor and provide technical guidance to junior validation engineers and cross-functional partners on validation principles and documentation
• Partner with Manufacturing, Quality, Automation, and Process Engineering to align validation timelines with production and project schedules
• Lead or support vendor/contractor qualification activities, including FAT/SAT coordination for new equipment and systems
• Drive continuous improvement of validation processes, templates, and risk-based approaches to reduce cycle time without compromising compliance
• Ensure all validation documentation and activities comply with FDA regulations, cGMP, and internal quality standards
• Represent validation function in cross-functional project teams for facility expansions, new product introductions, or major equipment installations

Qualifications

Required:

• Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, Pharmaceutical, or related field) or related science discipline
• 5+ years of validation experience in pharmaceutical, biotech, or medical device manufacturing
• Strong working knowledge of cGMP, FDA regulations (21 CFR Part 210/211, Part 11), and the full validation lifecycle (IQ/OQ/PQ, CSV, cleaning validation)
• Demonstrated experience authoring, executing, and approving validation protocols and reports independently
• Experience supporting or leading FDA/regulatory inspections as a validation SME
• Strong understanding of risk assessment methodologies (FMEA) and risk-based validation approaches
• Proficiency with MS Office (Excel, Word, PowerPoint) and validation/quality management systems (e.g., Veeva, TrackWise, or similar)
• Excellent written and verbal communication skills, with ability to influence cross-functional stakeholders and present to leadership
• Proven ability to manage multiple validation projects simultaneously, including timelines, resources, and stakeholder communication
• Willingness to work on the production floor, including gowning/cleanroom protocols as required