Validation Engineer

Overview

The Validation Engineer III serves as a key technical expert within the Manufacturing Science & Technology (MS&T) organization of our client, providing advanced knowledge and leadership for the site’s cleaning validation program. This role supports a diverse portfolio spanning pharmaceutical process development, technology transfers, late stage clinical programs, and commercial manufacturing.

The ideal candidate brings deep experience in cleaning validation for GMP environments, strong scientific judgment, and the ability to collaborate effectively across technical and operational teams. This position is highly visible and client-facing, requiring strong communication skills and a proactive approach to continuous improvement.

• Serve as the site subject matter expert for all cleaning validation activities, including oversight of the Cleaning Master Plan and validation strategies for clinical, launch, and commercial products.
• Build and maintain scientific understanding and technical capability for the site’s cleaning validation program.

• Author, review, and approve cleaning validation and verification protocols, reports, and associated documentation.
• Support creation and revision of manufacturing procedures and SOPs related to cleaning processes.
• Maintain all cleaning validation projects in an inspection ready state, including KPI tracking and data trending.
• Ensure validation activities align with global standards and cGMP requirements.

• Work on the manufacturing floor to support execution of cleaning validation studies.
• Provide training and technical guidance to Production and cross-functional teams.
• Own data analysis, routine monitoring, and lifecycle activities to ensure validated processes remain in control.
• Lead and facilitate risk assessments using appropriate risk management tools.
• Support deviation investigations, root cause analyses, and corrective/preventive action (CAPA) development.
• Own deviations, CAPAs, and audit responses associated with cleaning validation.

• Partner with QA, Manufacturing, Engineering, Project Management, Business Development, and external clients to support new product introductions and technical evaluations.
• Provide expert guidance regarding feasibility, process readiness, and regulatory expectations.

• Bachelor’s degree in Engineering or a science-related field with 7+ years of industry experience, or Master’s degree with 5+ years of industry experience.
• Minimum 4 years of hands-on experience supporting cleaning validation for Fill/Finish or Aseptic Process operations in a GMP commercial manufacturing setting.
• Equivalent education or experience may be considered.