Director of Validation

INCOG BioPharma Services•Fishers, IN

10d•Onsite

About The Position

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.

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

Nice To Haves

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

Responsibilities

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.