Process Validation Associate III

Responsibilities

• Support and maintain the process validation program.
• Develop, revise, and maintain process validation procedures, protocols, and summary reports.
• Partner with clients and internal teams to define validation scope, requirements, and objectives.
• Design, execute, and analyze technical studies using statistical tools to establish and evaluate process parameters.
• Perform risk assessments to support process validation activities.
• Plan, coordinate, and execute process validation activities for new and existing products.
• Analyze validation data and prepare documentation to support validation conclusions.
• Conduct annual reviews and Continued Process Verification (CPV) activities to ensure ongoing process performance.
• Lead or support investigations related to validation activities, including Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs).
• Maintain awareness of regulatory requirements and industry best practices to ensure compliance and continuous improvement.
• Create and maintain visual management tools and controls for the Process Validation group.
• Serve as a Subject Matter Expert (SME) for process validation during regulatory, client, and internal audits.
• Develop industry expertise and project proficiency while working independently on assigned initiatives.
• Identify and implement opportunities to optimize departmental processes and improve operational efficiency.

Qualifications

• Bachelor’s degree required, preferably in a science or engineering-related field.
• Minimum of 5 years of technical experience (validation preferred) in parenteral manufacturing.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).
• Ability to communicate effectively at all levels.
• Sound industry knowledge, project proficiency, and be able to work independently. May be considered a subject matter expert (SME) in various disciplines.
• Must be able to identify opportunities for optimization of processes within the department or the plant.
• Ability to work independently or in teams.