Validation Engineer III

Overview

The Validation Engineer III will serve as a key member of the validation team, providing expert-level support to ensure facility equipment, utilities, processes, instrumentation, and computerized systems are qualified and maintained in a validated state in compliance with applicable regulatory requirements. This role functions as a Validation Subject Matter Expert (SME) responsible for leading validation activities, authoring protocols and reports, and providing technical guidance to cross-functional teams.

The Validation Engineer III will coordinate and execute qualification activities while collaborating with internal stakeholders and external vendors to support ongoing operations and capital projects.

• Author, review, and approve validation protocols, reports, and associated documentation including acceptance criteria development
• Establish, revise, and maintain validation master plans, procedures, and lifecycle documentation for qualification of equipment, systems, and processes in accordance with cGMP requirements
• Execute and oversee IQ/OQ/PQ protocols for equipment, utilities, and systems
• Review and complete documentation in accordance with cGMP, ALCOA+ principles, and data integrity requirements
• Lead and manage validation-related project activities including scheduling, resource coordination, protocol execution, and report review
• Manage external vendors and contractors performing qualification activities
• Serve as a key member of project teams for design, procurement, installation, and commissioning of new equipment and facility expansion projects
• Develop and maintain validation project timelines and deliverables
• Review proposed changes to validated systems and provide impact assessments
• Identify validation requirements necessary to maintain systems in a validated state following change implementation
• Manage periodic requalification activities to ensure equipment, utilities, and processes remain compliant
• Support equipment and building monitoring systems compliance and updates
• Serve as Subject Matter Expert (SME) in one or more of the following disciplines:
  Process Mapping;
  Quality Management (Quality Risk Assessments; Change Controls; Deviations; CAPA; Documentation);
  Equipment qualification (autoclaves, controlled temperature units, filling equipment);
  Cleaning validation Aseptic process simulation (media fills);
  Computer system validation (CSV);
  Process validation Utility qualification (WFI, purified water, clean steam, HVAC);
  Environmental monitoring systems
• Provide technical guidance and troubleshooting support for equipment and system failures
• Deliver training on validation program elements to junior validation personnel
• Author and support equipment and process-related deviation investigations and CAPA activities
• Perform and support risk assessments (FMEA, etc.) and data integrity assessments
• Support internal audits and regulatory agency inspections
• Ensure all work is performed in accordance with SOPs, cGMPs, quality standards, and safety procedures

• Bachelor's degree in Engineering, Life Sciences, or related scientific discipline required
• Master's degree (MS/MSc) preferred

• Minimum 5+ years of professional experience in validation, engineering, or operations within a regulated environment
• Minimum 4+ years of direct experience in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environment
• Demonstrated expertise as a Subject Matter Expert (SME) in one or more validation disciplines
• Experience with GMP utilities (WFI, purified water, clean steam, compressed gases, HVAC) and manufacturing equipment
• Experience supporting regulatory inspections (FDA, EMA, or equivalent) preferred
• Capital project experience including equipment design, selection, and commissioning preferred

• Strong technical writing skills with ability to author clear, compliant documentation
• Solid working knowledge of cGMP regulations, FDA guidance documents, and industry standards (ISPE, PDA, GAMP)
• Understanding of GDP requirements and ALCOA+ data integrity principles
• Excellent communication and interpersonal skills with ability to interface across all organizational levels
• Strong project management and organizational skills
• Ability to work independently with minimal supervision while also functioning effectively in a team environment
• Self-motivated with demonstrated initiative and problem-solving abilities
• Proficiency in Microsoft Office Suite; experience with electronic validation systems a plus

• On-site presence required; may involve work in manufacturing, laboratory, and utility areas
• Ability to gown into cleanroom environments as required
• Occasional flexibility in schedule and travel may be needed to support project timelines or production schedules