Position Summary

The Director of Validation is responsible for leading and overseeing the validation lifecycle program across multiple FDA-regulated 503B outsourcing facilities. This position provides strategic and operational leadership for commissioning, qualification, validation, and continued process verification activities supporting sterile drug manufacturing, laboratory operations, facilities, utilities, computerized systems, and manufacturing processes.

The Director of Validation will establish and maintain a compliant, inspection-ready validation program across the Columbus and Denver sites, ensuring alignment of validation strategies, procedures, and execution while supporting business growth, capital projects, new product introductions, technology transfers, and regulatory inspections.

This role serves as the company subject matter expert for validation and qualification activities and works cross-functionally with Quality, Manufacturing, Engineering, Facilities, Metrology, Regulatory Affairs, Supply Chain, and R&D to ensure product quality, patient safety, and regulatory compliance.

Essential Duties and Responsibilities

Validation Program Leadership

• Develop, implement, and continuously improve the Validation Master Plan (VMP) for all facilities.
• Establish and maintain a robust validation lifecycle management program to ensure facilities, utilities, equipment, computerized systems, and manufacturing processes remain in a validated state throughout their lifecycle.
• Lead the development and execution of risk-based validation strategies in accordance with FDA regulations, cGMP requirements, USP standards, and industry best practices.
• Standardize validation methodologies, documentation practices, and compliance expectations across all sites.
• Establish departmental objectives, resource plans, budgets, and performance metrics aligned with organizational goals.
• Ensure validation programs support commercial manufacturing, facility expansions, and future business growth.

Multi-Site Validation Operations

• Provide leadership and execution supporting both Columbus and Denver operations.
• Manage validation projects, priorities, resources, and timelines across multiple sites.
• Ensure consistent execution of validation activities, procedures, and quality standards across facilities.
• Drive a culture of compliance, accountability, technical excellence, and continuous improvement.
• Mentor, develop, and lead validation personnel and technical subject matter experts.

Equipment, Facilities, Utilities, and Computer System Validation

• Oversee qualification and lifecycle management of:
  • Manufacturing equipment
  • Aseptic processing equipment
  • Syringe, bag, and line filling systems
  • Isolators and restricted access barrier systems (RABS)
  • Laboratory equipment
  • HVAC systems
  • Water systems
  • Compressed gas systems
  • Sterilization equipment
  • Controlled temperature environments
  • Cleanrooms and controlled environments
  • Computerized systems and software platforms
• Ensure appropriate execution of:
  • User Requirement Specifications (URS)
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Requalification activities
• Provide oversight for temperature mapping studies, facility qualifications, utility qualifications, and environmental monitoring program qualifications.

Process Validation and Sterile Manufacturing Action and Support

• Author, review, approve, and, when necessary, execute validation protocols, reports, engineering studies, and technical documentation supporting qualification and validation activities.
• Provide hands-on leadership for critical validation initiatives, including execution of commissioning, qualification, process validation, and requalification activities for manufacturing equipment, utilities, facilities, and computerized systems.
• Ensure timely development and approval of validation deliverables including Validation Master Plans (VMPs), User Requirement Specifications (URS), risk assessments, FAT/SAT documentation, IQ/OQ/PQ protocols, summary reports, and lifecycle management records.
• Lead execution of complex validation projects and provide technical oversight to ensure activities are completed in accordance with approved protocols, regulatory requirements, and project timelines.
• Review and analyze validation data, deviations, and test results to determine acceptability, identify trends, and support scientifically sound conclusions.
• Author and approve standard operating procedures (SOPs), work instructions, validation procedures, and qualification standards to maintain compliance with FDA, cGMP, USP, and state regulatory requirements.
• Participate directly in validation activities during facility expansions, new equipment installations, technology transfers, remediation efforts, and regulatory commitments as business needs require.
• Ensure validation documentation is inspection-ready, technically accurate, and maintained in accordance with document control and data integrity requirements.
• Provide technical review and approval of change controls, deviations, investigations, CAPAs, and risk assessments related to validated systems and processes.
• Direct process validation strategies for aseptic manufacturing, sterile compounding, sterile filling, and terminal sterilization processes.
• Oversee process performance qualification (PPQ) and continued process verification (CPV) programs.
• Provide leadership for media fills, aseptic process simulations, sterilization validation, and contamination control initiatives.

Asset Lifecycle, Metrology, and Maintenance Programs

• Provide oversight for validation-related asset lifecycle management programs.
• Partner with Facilities and Metrology teams to ensure preventive maintenance, calibration, and requalification programs maintain compliance and equipment reliability.
• Establish governance for asset management practices, including equipment upgrades, replacement planning, retirement strategies, and lifecycle documentation.
• Ensure validated systems remain inspection-ready through effective maintenance and change management practices.

Vendor and Contractor Management

• Manage external validation consultants, engineering firms, contractors, and service providers.
• Ensure third-party validation activities are executed in accordance with regulatory requirements and company procedures.
• Evaluate vendor performance and support supplier qualification activities when required.

Continuous Improvement

• Identify opportunities to improve validation systems, processes, and operational performance.
• Implement risk-based and science-based approaches to improve compliance, efficiency, and scalability.
• Support enterprise continuous improvement initiatives and operational excellence programs.
• Leverage industry best practices and emerging technologies to strengthen validation and qualification programs.

Required Qualifications

Education

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Chemistry, Biology, Microbiology, or related scientific discipline required, in leu of a degree experience of 20 or more years of Validation leadership in a cGMP manufacturing environment is required.

Experience

• 10+ years of progressive experience within pharmaceutical, biologics, sterile manufacturing, or regulated healthcare manufacturing environments.
• Minimum 5 years of leadership experience managing validation, engineering, or technical operations teams.
• Direct experience supporting FDA-regulated manufacturing operations.
• Extensive experience supporting sterile manufacturing and aseptic processing environments.
• Proven experience leading multi-site validation programs and cross-functional project teams.
• Experience supporting regulatory inspections and remediation activities.

Technical Knowledge

• Expert knowledge of:
  • FDA cGMP regulations
  • 21 CFR Parts 210 and 211
  • USP <797> and applicable USP standards
  • Annex 1 contamination control principles
  • ISPE guidance
  • GAMP 5 principles
  • FDA Process Validation Guidance
  • Data Integrity requirements
  • Risk Management principles
• Strong expertise in:
  • URS, FAT, SAT, IQ, OQ, and PQ methodologies
  • Process Validation and Continued Process Verification
  • Cleaning Validation
  • Computer System Validation
  • Temperature Mapping
  • Environmental Qualification
  • Sterilization Validation
  • Aseptic Media Fills
  • Calibration and Metrology Programs
  • Asset Lifecycle Management

Travel Requirements

• Up to 20% travel between Columbus, Ohio and Denver, Colorado facilities.
• Occasional travel for regulatory inspections, vendor audits, project support, and industry conferences.