Validation Engineer

Position Summary

The Validation Engineer is responsible for ensuring the reliability, consistency, and regulatory compliance of manufacturing processes, equipment, and computerized systems. This role leads the development and execution of validation documentation and activities—including process, equipment, and system validation—to support regulatory requirements and internal quality standards. The Validation Engineer II works cross-functionally, independently manages projects, and provides technical guidance with minimal oversight.

There are three levels available (Validation Engineer I, II, and Senior), with the Engineer II expected to operate autonomously on moderately complex projects and contribute to continuous improvement initiatives.

Key Responsibilities

• Lead the preparation, execution, and review of validation documentation, including:
• User Requirements Specifications (URS)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation Summary Reports (VSR)
• Independently lead and coordinate cross-functional validation projects, ensuring timelines, scope, and deliverables are met.
• Perform critical review of Validation Engineer project plans and validation documentation to ensure accuracy, completeness, and compliance.
• Develop and execute validation plans for new and existing processes, equipment, and computerized systems.
• Execute process validation and equipment qualification activities, including defining acceptance criteria, troubleshooting equipment, and ensuring compliance with safety and quality standards.
• Support and maintain the company Master Validation Plan (MVP), including commissioning activities, protocol execution, and revalidation criteria.
• Assess the validation impact of process, material, equipment, or system changes and provide guidance on change control and revalidation requirements.
• Conduct impact and risk assessments in collaboration with system owners to determine qualification and validation needs.
• Identify validation and manufacturing risks and implement effective mitigation strategies.
• Review technical data and validation results, and present findings to internal stakeholders and management.
• Support validation activities related to sterilization processes and micro validation efforts
• Ensure compliance with all applicable federal, state, regulatory, and company policies and procedures.
• Coordinate external validation or testing services when required.
• Perform additional duties as assigned.

Qualifications

Education & Experience

• Bachelor’s degree in Engineering or a related technical discipline (e.g., Biology, Chemistry); microbiology background preferred.
• 2–5 years of experience in an engineering role, with hands-on validation experience preferred.
• Experience in regulated industries such as Tissue Banking, Pharmaceutical, Medical Device, or Biologics.

Technical Skills & Knowledge

• Strong knowledge of regulatory and quality guidelines (e.g., FDA, AATB, cGTP preferred).
• Experience with:
• Process validation and equipment validation
• Nonconformance, deviation, complaint handling, and CAPA processes
• Sterilization validation (strong plus)
• Microvalidation / microbiological validation (strong plus)
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project.

Core Competencies

• Strong analytical, problem-solving, and technical writing skills.
• Effective verbal and written communication and presentation abilities.
• Project management capability with the ability to manage multiple priorities.
• Ability to work independently, influence others, and lead change across cross-functional teams.