Validation Engineer

Responsible for ensuring that equipment, process, and analytical methods are validated. Supports production by providing ongoing quality engineering support throughout the product life cycle and performs Non Conformance (NC) and Out Of Specification (OOS) investigations.

• Review and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), test method validation protocols (TMV), and analytical test methods.
• Provide guidance and direction to teams upon review of validation documentation.
• Serve as a hands‑on Validation Lead for validation of changes to existing processes, systems, and equipment.
• Review equipment manuals, specifications, drawings, and operational documents to ensure validation and qualification protocols and standard operating procedures align with manufacturer specifications, operational procedures, calibration requirements, and maintenance requirements.
• Perform Non‑Conformance (NC) and Out Of Specification (OOS) investigations.
• Analyze processes and methods related to quality improvement (e.g., Six Sigma, statistical tools), product and process risk management (PFMEA), and corrective and preventive action (CAPA).
• Assist with audits by explaining validation and qualification activities performed at the site.
• This is not an exhaustive list of duties or functions and may not necessarily comprise all essential functions for purposes of the Americans with Disabilities Act.

• Proven ability to write technical documentation.
• Proven ability to write analytical method requirements and tests.
• Ability to lead and prioritize tasks and drive projects to completion.
• Ability to communicate clearly and concisely, including experience writing technical documentation.
• Ability to work effectively in a team environment.
• Strong organizational and interpersonal skills.

• Bachelor of Science degree in a relevant field (science, engineering, or related discipline).
• 5–7 years of related experience or an equivalent combination of education and experience.