Validation Engineer

Responsibilities

• Support development and execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, and processes
• Assist in authoring and executing Computer System Validation (CSV) protocols for GxP systems in compliance with 21 CFR Part 11 and GAMP 5 principles
• Support process validation activities, including protocol development, execution, and data collection for new and existing manufacturing processes
• Assist with cleaning validation studies, including sampling, protocol execution, and documentation
• Document validation results, deviations, and discrepancies, and support root cause analysis and resolution
• Collaborate with Manufacturing, Quality Assurance, Process Engineering, and Automation teams to coordinate validation activities and timelines
• Support authoring and updating validation master plans, risk assessments, and validation summary reports
• Assist with change control activities related to equipment, process, or system modifications requiring revalidation
• Support internal audits and prepare for external regulatory inspections (FDA, ISO) by compiling validation documentation and data
• Ensure all validation activities and documentation comply with FDA regulations, cGMP, and internal quality standards
• Participate in continuous improvement initiatives to streamline validation processes and reduce cycle times
• Maintain accurate, audit-ready documentation for all validation protocols, execution records, and reports

Qualifications

Required:

• Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, Pharmaceutical, or related field) or related science discipline
• 0–2 years of relevant experience (internships, co-ops, or entry-level validation/quality roles in pharma/biotech/med device count)
• Basic understanding of cGMP, FDA regulations (21 CFR Part 210/211, Part 11), and validation lifecycle (IQ/OQ/PQ)
• Familiarity with validation documentation practices, including protocol writing and execution
• Proficiency with MS Office (Excel, Word, PowerPoint); familiarity with validation/quality management software a plus
• Strong written and verbal communication skills, with the ability to author clear, audit-ready technical documentation
• Ability to work effectively in a cross-functional, highly regulated team environment
• Willingness to work on the production floor, including gowning/cleanroom protocols as required