Job Description
We are actively seeking a Principal QA Process Validation Specialist to provide technical Quality oversight and subject matter expertise for process validation activities supporting aseptically filled drug products.
This role is ideal for a Process Validation Engineer or Validation SME with strong technical expertise who can evaluate validation strategies, review engineering activities, and ensure processes are scientifically sound, compliant, and aligned with regulatory expectations.
The Principal QA Process Validation Specialist will partner closely with Process Engineering, MSAT, Manufacturing, Validation, and Quality teams to provide oversight throughout the full process validation lifecycle, including Process Design, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).
This individual will leverage their hands-on process validation background to ensure validat...