Validation Engineer

Validates and revalidates new or modified products, equipment or systems. Provides technical support to Operations in terms of equipment/system initial validation and equipment/system requalifications.

Salary Range: $60,966-$85,694 annually

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

• Performs equipment requalifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Analyzes data, composes a Final Report and circulates for approval.
• Executes equipment validation studies per SOPs or utilizing reference templates, to include protocol preparation, scheduling, protocol execution, data analysis, Final Report preparation and circulation for approval.
• Programs and operates department analytical instruments (such as temperature/humidity data loggers and thermocouples) to perform controlled temperature/humidity chamber qualifications/requalifications(i.e.: lyophilizers, sterilizers, depyrogenation ovens/tunnels, warehouses, coolers/freezers, incubators, etc.).
• Participates in improvements to validation programs/procedures as needed to remain current with cGMPs and industry standards.
• Participates in teams assembled to validate and maintain systems and equipment.
• Participates in deviation investigations and corrective and/or preventative actions (CA/PA).