INCOG BioPharma Services Careers - Director of Validation

INCOG Biopharma Services seeks an experienced, strategic Director of Validation to lead the validation function across our GMP-certified sterile injectable drug product manufacturing and device assembly operations. This role ensures that all manufacturing equipment, processes, and systems operate in accordance with FDA regulations, ICH guidelines, and industry best practices. The Director will drive a culture of quality excellence, compliance, and continuous improvement while supporting operational efficiency and client success. Essential Job Functions: * Validation Strategy & Oversight: Develop and implement comprehensive validation strategies aligned with INCOG's quality objectives, including equipment IQ/OQ/PQ protocols, process validation studies, cleaning validation, and computer system validation across sterile injectable and device assembly operations. * Protocol Development & Execution: Lead the creation, approval, and execution of validation protocols and reports. Ensure all protocols meet regulatory expectations. Coordinate with Manufacturing, Engineering, and Quality to define acceptance criteria and deliverables. * Compliance & Regulatory Knowledge: Maintain current knowledge of FDA regulations, 21 CFR Parts 210/211, ICH Q7, EMA/Annex 1, ISO and USP standards. Ensure all validation activities support regulatory compliance and product registrations. Serve as a subject matter expert during regulatory inspections and audits. * Team Leadership: Build, mentor, and manage a validation team. Foster a collaborative environment that emphasizes quality, scientific rigor, and attention to detail. Develop team members' technical expertise and career growth. * Risk-Based Decisions: Apply sound risk assessment principles (FMEA, statistical analysis) to validation planning. Justify deviations and determine appropriate corrective actions when validation results fall outside acceptance criteria. * Process Validation: Oversee process validation studies for aseptic processes, and device assembly operations. Ensure adequate data collection, statistical rigor, and scientific justification for commercial manufacturing. * Equipment & System Qualification: Direct IQ/OQ/PQ activities for new equipment installations and process modifications. Manage vendor coordination, test plan reviews, and performance verification. * Cleaning Validation: Lead cleaning validation programs across manufacturing suites and equipment. Establish acceptance criteria, analytical methods, and ongoing monitoring protocols to ensure standards are met. * Documentation & Record Keeping: Ensure all validation documentation is complete, accurate, and traceable. Maintain master validation plans and support batch record reviews and exception handling as needed. * Continuous Improvement: Identify opportunities for validation process improvements, efficiency gains, and cost optimization without compromising quality or compliance. Champion a lean quality approach. * Cross-Functional Collaboration: Partner with Quality Assurance, Manufacturing Operations, Engineering, and Technical Services to align validation timelines with project needs. Support manufacturing troubleshooting and root cause investigations. * Occasional Travel: This role is based in our Fishers, Indiana facility and may involve occasional travel for regulatory meetings, industry conferences, or client visits. The position requires regular time in the manufacturing environment wearing appropriate personal protective equipment (PPE) and following GMP protocols. Special Job Requirements: * Bachelor's degree in Chemistry, Engineering, Pharmaceutical Sciences, or related life sciences discipline (Master's preferred) * Minimum 12+ years of pharmaceutical manufacturing experience, with at least 5 years in a validation leadership or senior technical role * Demonstrated expertise in IQ/OQ/PQ methodology, process validation, and cleaning validation in a GMP environment * Strong understanding of sterile manufacturing and aseptic processes, preferably in injectable products or similar highly regulated environments * Proven ability to lead, mentor, and develop technical teams * Excellent communication skills, both written and verbal, with ability to translate technical concepts for various audiences * Strong problem-solving and decision-making abilities with a risk-based, data-driven mindset * Project management experience and ability to manage multiple validation initiatives simultaneously * Familiarity with statistical methods, design of experiments (DOE), and analytical techniques Additional Preferences: * Experience with contract manufacturing organizations (CDMOs) or similar outsourced service environments * Background in computer system validation or IT validation * Experience with quality by design (QbD) principles and application * Prior experience with regulatory inspections and audit support * Knowledge of QMS, EMS, ERP, and CMMS systems such as Veeva, SAP, Kneat, Blue Mountain * Six Sigma or Lean certification Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

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