Senior Validation Engineer

GSK•King of Prussia, PA

1d•Onsite

About The Position

This role will be responsible for equipment/facility/computer validation projects in a hands-on role including writing validation protocols, scheduling, and executing testing, gathering, and analyzing data, and writing validation summary reports. This person will participate as a leading team member representing validation on project teams.

Requirements

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.

Nice To Haves

Advanced degree in engineering, life sciences, or related discipline.
Experience leading projects or supervising small technical teams.
Experience with computerized system validation, including lifecycle documentation and 21 CFR Part 11 concepts.
Familiarity with commissioning and qualification of utilities and automation systems.
Training in Lean, Six Sigma, or continuous improvement methods.
Strong interpersonal skills and experience working with cross-functional stakeholders.

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 system.
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.
Development of 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.
Development of 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).