Senior Engineer, Process Validation

Aldevron, a Danaher operating company, seeks a Senior Engineer to lead process validation projects supporting commercialization of therapies. The role involves designing and executing validation strategies across drug substance and product stages, managing sterile fill-finish qualification programs, and applying risk-based approaches and statistical tools. The position reports to the Process Validation Manager and is fully remote.

Responsibilities

• Design and execute process validation across characterization, qualification, and commercial stages
• Lead sterile fill-finish and aseptic manufacturing process validation strategies and programs
• Apply risk-based approaches and statistical tools to evaluate process performance
• Serve as technical subject matter expert for external clients and internal teams during audits and inspections
• Mentor junior validation associates in cGMP regulations and Quality by Design principles

Requirements

• Bachelor's or Master's degree in engineering
• 5+ years of process validation experience in biologics manufacturing
• Knowledge of global regulatory requirements and cGMP regulations
• Proficiency in technical writing, deviation investigations, and root cause analysis
• Experience with statistical analysis, risk assessment, and process improvement tools
• Familiarity with FDA guidance and EU GMP Annex 15 requirements

Compensation: $100,000-$130,000 base, plus bonus/incentive pay eligible