Validation Manager

Description Leadership & Strategy Develop and implement site-wide CQV strategies aligned with regulatory and business objectives. Cleaning validation Stability programs Packaging configurations for intermediate and finished goods. Lead, mentor, and develop CQV engineers and validation specialists. Establish validation master plans (VMPs) and lifecycle validation programs. Manage CQV budgets, schedules, and resource planning. Commissioning & Qualification Oversee commissioning and qualification of: Manufacturing equipment Clean utilities (WFI, clean steam, compressed gases) HVAC systems and cleanrooms Laboratory systems Process automation and control systems Establish and implement cleaning validation requirements. Establish and implement packaging configurations Stability programs and protocols Ensure execution of URS, FRS, DS, FAT, SAT, IQ, OQ, and PQ protocols. Coordinate with Engineering, Quality, Manufacturing, and external vendors. Validation Lifecycle Management Ensure compliance with: FDA 21 CFR Parts 210/211, 11 EU GMP Annex 1 & 15 ICH guidelines ISPE Baseline Guides Oversee process validation, cleaning validation, and continued process verification (CPV). Support technology transfer and new product introductions (NPI). Documentation & Compliance Review and approve validation protocols and reports. Ensure data integrity and adherence to ALCOA+ principles. Support internal audits, regulatory inspections, and client audits. Manage deviation investigations, CAPAs, and change controls related to CQV. Risk Management Apply risk-based validation approaches (ICH Q9). Conduct and facilitate FMEAs and risk assessments. Implement continuous improvement initiatives in validation processes. Requirements Education Bachelor's degree in Engineering, Pharmaceutical Sciences, or related technical field (Master's preferred). Experience 8+ years of experience in pharmaceutical/biotech manufacturing. 5+ years in CQV/validation leadership role. Strong knowledge of GMP-regulated environments. Experience supporting regulatory inspections. Technical Skills Deep understanding of validation lifecycle approach. Expertise in cleanroom and sterile manufacturing qualification (preferred). Knowledge of automation systems (DeltaV, Siemens, etc.). Familiarity with Kneat, ValGenesis, TrackWise, or similar systems (preferred). Soft Skills Strong leadership and team management skills. Excellent communication and stakeholder engagement abilities. High attention to detail and organizational skills. Ability to manage multiple complex projects simultaneously. Key Competencies Regulatory Compliance Expertise Project Management Risk-Based Thinking Cross-Functional Collaboration Problem Solving & Decision Making Continuous Improvement Preferred Certifications: PMP (Project Management Professional) ASQ Certified Quality Engineer (CQE) ISPE membership or relate industry certifications Physical Requirements Majority of time spent in a manufacturing environment with potential exposure to chemicals and controlled substances. Must be able to wear appropriate PPE and occasionally lift up to 30 pounds. May be required to be on call or work off-hours to support 24/7 operations.

Created: 2026-03-04