Validation Engineer

Key Responsibilities

• Strong Experience in Computer Systems Validation (CSV) within the pharmaceutical industry.
• Required Bachelor's degree in pharmaceutical Science OR related field of study.
• Schedule and plan equipment and process qualification workload to meet approved schedules.
• Handle multiple projects and be able to work independently as required.
• Develop GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional Design Specifications, Configuration Specifications, Testing Protocols (IQ/OQ/PQ/VSR/Deviations), User Acceptance testing, Traceability matrix, System and Validation reports, SOPs, Change Control Documentation, and Risk assessment/FMEA reports as required.
• Establish critical parameters, plan, design, and implement validation projects and protocols.
• Ability to author, execute, and thoroughly review complex protocols and documentation.
• Coordinate validation activities with other departments.
• Stay current with industry qualification trends through FDA, ISPE, EU and bench marked companies.
• Consult, coordinate, cross-function with various personnel within the company and externally.
• Have the ability to problem solve with minimal oversight, including conducting research to aid in the resolution of issues that arise.
• Train and mentor other Validation personnel as necessary.
• Determine and acquire necessary supplies and equipment for validation activities (Planning).
• Administer the site Change Control/Management Program.
• Make decisions representing QA in multi-functional teams.
• Plan and assist with the Global serialization project (as necessary).
• Familiarity and experience with TrackWise, LIMS, ComplianceWire, JDE, GAMP is desirable

Key Requirements  

• Minimum Bachelor’s Degree
• Significant experience in pharmaceutical/biotechnology or related industry, as well as Quality Assurance
• Cleaning Validation/Process Validation experience preferred
• Experience with commissioning/qualification of equipment, change management or change control experience
• Independent and flexible worker that can readily adapt to changing priorities in a fast-paced environment
• Demonstrated attention to detail and excellent oral and written communication skills