Senior Validation Engineer

Responsibilities

• Lead validation test activities, collect and analyze data, and drive timely resolution of deviations.
• Plan, write, and execute validation protocols and final reports for equipment, utilities, facilities, and computerized systems.
• Cook up and execute validation protocols and final reports for equipment, utilities, facilities, and computerized systems.
• Coordinate cross-functional teams, vendors, and contractors to meet project timelines.
• Maintain and update validation project plans and the Site Validation Master Plan.
• Mentor and coach junior validation staff to build capability and consistency in execution.
• Support audits and regulatory inspections by preparing documentation and responding to findings.
• Oversee the development of, and participate in, required validation studies and protocols for analytical equipment and computer systems and lead the effort to approve protocols and associated reports.
• Assist and guide the development of specification documentation to ensure it complies with current validation standards and QMS methodologies, and systems are able to be adequately validated.
• Develop procedures, practices, and policies related to computer system validation.
• Monitor and update the Validation Master Plan to ensure that it complies with appropriate regulatory guidelines and standard practices.
• Provide leadership in setting priorities, fulfilling customer needs, defining timelines, and tracking projects.
• Ensure team deliverables are met within defined timelines.
• Interface with other departments to coordinate resources and complete validation activities in a timely manner.
• Develop Validation Project Plans to support major changes to the site and develop the team to become proficient in validation activities (e.g., analytical equipment qualification and computer system validation).

Qualifications

• 8+ years of relevant technical experience with a minimum 5 + years’ hands-on validation experience in a regulated environment (equipment, facility, utilities, or computerized systems).
• Bachelor’s degree in engineering, life sciences, computer science, or a related technical field or associate's degree in engineering, life sciences, biology with 8 plus years of technical experience.
• Experienced required with hardware, software, specifically, Microsoft Windows operating system settings and configuration, process control systems, databases, writing and executing IQ, OQ, PQ or equivalent validation protocols.