Process Validation Engineer I

Role Responsibilities

• Process Validation & PPQ: Author and execute Process Performance Qualification (PPQ) protocols, reports, sampling plans, and validation documentation.
• Support development and implementation of process validation strategies in accordance with FDA, EMA, and ICH guidelines.
• Capture and analyze validation data to assess process capability and performance.
• Analyze process risk assessments using tools such as FMEA and process mapping.
• Ensure validation activities are completed in compliance with cGMP requirements and site procedures.
• Continued Process Verification (CPV): Monitor and trend critical process parameters (CPPs) and critical quality attributes (CQAs).
• Generate CPV reports and evaluate process performance data to identify trends and opportunities for improvement.
• Support investigations related to process deviations, out-of-trend results, and process excursions.
• Participate in implementation and verification of corrective and preventive actions (CAPAs).
• Technology Transfer Support: Support technology transfer activities for new products, process improvements, and manufacturing scale-up projects.
• Aid in developing process descriptions, manufacturing instructions, and transfer documentation.
• Support process fit-gap assessments and risk evaluations.
• Participate in equipment qualification, facility readiness assessments, and process characterization activities.
• Process Monitoring & Continuous Improvement: Utilize statistical tools and process data to identify process variability and opportunities for optimization.
• Support process robustness initiatives and operational excellence projects.
• Assist in development of process control strategies and process capability assessments.
• Participate in root cause investigations and implementation of process improvements.

Documentation & Compliance

• Prepare, review, and maintain validation protocols, reports, technical assessments, and supporting documentation.
• Ensure documentation is accurate, complete, and inspection-ready.
• Support change control assessments and validation impact evaluations.
• Participate in internal audits, customer audits, and regulatory inspections as a subject matter expert for assigned validation activities.

Cross-Functional Collaboration

• Work closely with Manufacturing, Quality, Process Development, Regulatory Affairs, and Engineering teams.
• Provide technical support for manufacturing operations and process troubleshooting.
• Aid in regulatory submissions and responses related to process validation and manufacturing process performance.
• Present validation findings and recommendations to cross-functional teams and site leadership.