Validation Engineer

Summary

Responsible for independently performing validation activities, including writing protocols and reports and compiling data and attachments into comprehensive validation packages. Also responsible for assisting with the development of procedures, specifications, validation protocols and other validation and engineering related documentation. May also perform routine preventive maintenance activities and manage validation and revalidation projects.

Essential Duties:

• Work on multiple validation projects simultaneously and coordinate test work with various other departments.
• Write protocols for manufacturing, utility and lab equipment and processes.
• Execute validation work according to protocol instructions and procedures.
• Plan, coordinate and track the progress of validation projects.
• Compile validation packages and assure all required documentation is complete.
• Review validation data for other staff.
• Assist in development of the Maintenance and Calibration programs and associated procedures.
• Champion process improvement projects and ensure equipment and systems remain in a qualified state.
• Assist with the implementation of a validation training program and the training of new personnel and contractors.
• Assure compliance with quality policies and procedures related to validation activities.
• Lead investigations related to validation deviations and assure thoroughness of investigation, documentation and closure.
• Other duties as assigned.

Qualifications:

• BS in Biology, Chemistry, Engineering or related science or equivalent experience
• Excellent technical writing and organizational skills
• Self-starting and multitasking
• Extremely detail oriented
• 3-7 years of experience in a cGMP manufacturing environment including hands-on validation experience
• Ability to work with cross functional teams and meet performance requirements
• Good interpersonal skills and the ability to work well in a team environment