Process Validation Engineer

Job Summary

The Process Validation Engineer I supports the design, execution, and documentation of process validation activities to ensure compliance with regulatory requirements, quality standards, and operational efficiency. This role partners with cross-functional teams to validate new and existing processes, analyze data for process capability, and drive continuous improvement within a cGMP-regulated environment.

Job Responsibilities

• Develop, execute, and review process validation protocols (e.g., PV, PPQ) and reports.
• Perform risk assessments (e.g., FMEA, HACCP) to identify critical parameters and ensure process control.
• Analyze and interpret validation data to establish process capability and consistency using statistical tools.
• Author and maintain validation protocols, reports, and SOPs in compliance with FDA, EU, and ICH guidelines.
• Collaborate with R&D, Manufacturing, Engineering, and QA/QC on technology transfer, new product introductions, and process improvements.
• Investigate process deviations, support CAPA implementation, and recommend corrective actions.
• Evaluate and implement technologies to enhance process robustness and reliability.
• Ensure audit readiness by maintaining complete, accurate, and compliant documentation.
• Support internal and external inspections by demonstrating validated processes.
• Provide training on validation procedures, protocols, and best practices.
• Prepare periodic summaries and metrics of validation activities.
• Perform other duties as assigned.

Qualifications

Education

• Bachelor’s degree in Engineering, Chemistry, Biotechnology, or a related field. Advanced degree preferred.

Knowledge, Skills and Abilities

• Solid understanding of cGMP, FDA, EU, and ICH validation requirements (21 CFR Parts 210/211, ICH Q8/Q9/Q10).
• Proficiency with statistical analysis software (e.g., JMP, Minitab).
• Strong analytical, problem-solving, and technical writing skills.
• Effective communication, teamwork, and organizational abilities.
• Familiarity with manufacturing equipment, cleanroom operations, aseptic/sterile processing, and cleaning validation.
• Ability to manage multiple projects in a fast-paced environment.

Experience

• 1–3 years of experience in process validation within a regulated manufacturing environment (pharmaceutical, biotechnology, or medical device industry).
• Hands-on experience with validation protocols, troubleshooting, and process improvements.