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
• Lead or support investigations related to validation activities, including NCRs and CAPAs
• Serve as a Subject Matter Expert (SME) during regulatory, client, and internal audits

Requirements

• Bachelor’s degree in a science or engineering-related field
• Minimum of 5 years of technical experience in parenteral manufacturing
• Proficiency in Microsoft Word, Excel, and Outlook
• Experience with enterprise software such as JDE, BPLM, Pilgrim, or Trackwise
• Ability to gown for Grade C environments
• Ability to work overtime, including nights and weekends

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.