Sr. Validation Manager

Leadership & StrategyDevelop and implement site-wide CQV strategies aligned with regulatory and business objectives.Cleaning validationStability programsPackaging 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 & QualificationOversee commissioning and qualification of:Manufacturing equipmentClean utilities (WFI, clean steam, compressed gases)HVAC systems and cleanroomsLaboratory systemsProcess automation and control systemsEstablish and implement cleaning validation requirements.Establish and implement packaging configurationsStability programs and protocolsEnsure execution of URS, FRS, DS, FAT, SAT, IQ, OQ, and PQ protocols.Coordinate with Engineering, Quality, Manufacturing, and external vendors.Validation Lifecycle ManagementEnsure compliance with:FDA 21 CFR Parts 210/211, 11EU GMP Annex 1 & 15ICH guidelinesISPE Baseline GuidesOversee process validation, cleaning validation, and continued process verification (CPV).Support technology transfer and new product introductions (NPI).Documentation & ComplianceReview 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 ManagementApply risk-based validation approaches (ICH Q9).Conduct and facilitate FMEAs and risk assessments.Implement continuous improvement initiatives in validation processes.RequirementsEducationBachelor's degree in Engineering, Pharmaceutical Sciences, or related technical field (Master's preferred).Experience8+ 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 SkillsDeep 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 SkillsStrong 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 CompetenciesRegulatory Compliance ExpertiseProject ManagementRisk-Based ThinkingCross-Functional CollaborationProblem Solving & Decision MakingContinuous ImprovementPreferred Certifications:PMP (Project Management Professional)ASQ Certified Quality Engineer (CQE)ISPE membership or relate industry certificationsPhysical RequirementsMajority 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.