Process & Cleaning Validation Specialist II

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions: Office Job Description: Job Summary: The Process & Cleaning Validation Specialist II independently manages validation and continued process verification activities for sterile manufacturing processes, cleaning procedures, and aseptic process simulations (APS/Media Fill). The role ensures full lifecycle process validation (Stage 2 – Process Qualification and Stage 3 – Continued Process Verification) and guarantees maintenance of the validated state through data-driven monitoring and proactive risk management, in compliance with GMP and regulatory requirements. The Specialist II operates autonomously within assigned projects and acts as a technical reference point for validation topics within cross-functional teams. Key Responsibilities: Validation Strategy & Technical Assessment: Independently analyze technical documentation related to manufacturing processes and cleaning procedures. Identify Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) and define risk-based validation approaches. Perform and update risk assessments related to cross-contamination and process robustness. Define revalidation strate...