Senior Validation Manager

Kindeva Drug Delivery•St. Louis, MO

1d•Onsite

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The Senior Manager, Validation provides enterprise-level leadership and strategic oversight for equipment, facilities, utilities, and controlled temperature system validation across multiple pharmaceutical manufacturing sites. This role serves as the validation authority for infrastructure and manufacturing equipment lifecycle management and establishes the long-term vision, governance model, and compliance strategy for sustaining an inspection-ready state. This position maintains exclusive accountability for validation of: Manufacturing equipment Small molecule and biological drug product processing & complex formulation equipment Incubators and temperature-controlled units cGMP Facilities (HVAC, utilities etc.) This role does not own product process validation or media fill qualification (technical input provided as required). The Senior Manager, Validation will architect and govern the Site Validation Master Plan (SVMP), oversee facility-related Site Master File (SMF) strategy, and embed lifecycle validation principles across all sites from design, start up, routine requalification through decommissioning.

Requirements

Bachelor’s degree in Engineering or related technical discipline required. Advanced degree preferred.
15+ years of pharmaceutical validation experience.
10+ years experience leading end-to-end validation programs within: Small Volume Parenteral (SVP) manufacturing Biologic pharmaceutical operations / Drug Product Sterile formulation and aseptic filling Automated inspection and packaging systems Cold storage and controlled temperature systems
Demonstrated, proven experience in: Startup of new GMP manufacturing facilities (major expansions) Lifecycle management and modernization of legacy facilities Multi-site validation governance Capital project validation leadership Regulatory inspection management (FDA and international agencies) Annex 1 implementation Cold chain qualification and temperature mapping programs Lifecycle validation strategy (ASTM E2500 preferred)

Responsibilities

Establish and lead a harmonized, multi-site validation governance model.
Define lifecycle validation standards aligned with FDA, EMA, ICH, and Annex 1.
Serve as enterprise subject matter authority during regulatory inspections.
Implement risk-based validation strategy consistent with ASTM E2500 principles.
Ensure sustained state-of-control across both newly commissioned and legacy facilities.
Provide executive oversight for validation lifecycle activities including: Aseptic formulation, filling and cleaning validation Aseptic filling lines (vials, syringes, cartridges) Automated visual inspection platforms Packaging systems (serialization, labeling, cartoning) Cold storage systems (CRT warehouse storage, cold rooms, stability chambers) Critical GMP support systems (autoclaves, utilities, HVAC etc.)
Maintain governance over: URS development standards Design Qualification (DQ) strategy FAT and SAT execution oversight IQ/OQ/PQ framework approval Continued verification programs Requalification and decommissioning lifecycle management
Maintain enterprise accountability for validation of: HVAC systems (classified sterile environments) Clean utilities (WFI, clean steam, compressed gases) Plant utilities impacting GMP operations Controlled temperature areas (warehouses, GMP rooms, staging, distribution) Environmental monitoring infrastructure Temperature mapping and cold chain programs
Develop long-term strategy for lifecycle maintenance of validated state across both modern and aging facilities.
Author and govern the Site Validation Master Plan (SVMP).
Establish validation philosophy embedded within regulatory submissions.
Oversee facility- and equipment-related components of the Drug Master File (DMF).
Ensure defensible validation documentation during inspections.
Align validation strategy with Quality and Regulatory Affairs leadership.
Strategic partnership with: MS&T (Manufacturing Science & Technology) for alignment between equipment capability and process performance. Metrology to ensure calibration strategy supports validated state and data integrity. Manufacturing Engineering to integrate lifecycle validation principles into equipment design and installation. Quality Assurance for compliance strategy and inspection readiness.
Lead validation managers, engineers, and specialists across sites.
Establish competency frameworks and structured development pathways.
Drive cross-site standardization and best-practice adoption.
Build succession planning and scalable validation infrastructure.
Promote a culture of accountability, technical excellence, and inspection readiness.