Validation Engineer III

Job Description:

Job Summary

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.

Key Responsibilities

Validation Documentation & Execution

• 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
  
  
  

Project & Program Management

• 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
  
  
  

Compliance & Change Control

• 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
  
  
  

Technical Expertise

• 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
  
  

Quality Systems Support

• 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
  
  
  

Qualifications

Education

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

Experience

• 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
  
  
  

Skills & Competencies

• 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
  
  
  

Working Conditions

• 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
  
  
  

er will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility, and process equipment.