Senior Validation Engineer
GSK
June 30, 2026
On-site
King of Prussia, PA
Operations
Position Summary:
This role is responsible for understanding modern computer systems and control/digital systems within the facility and leading validation projects for equipment, facilities, utilities, and computerized systems. Responsibilities include writing/reviewing validation protocols, running/supervising testing, analyzing results, and authoring final reports with engineering, quality, operations, and IT.
Responsibilities:
- Lead validation test activities; plan, write, and execute validation protocols and final reports; collect/analyze data and resolve deviations.
- Coordinate cross-functional teams, vendors, and contractors; maintain validation project plans and the Site Validation Master Plan.
- Mentor junior validation staff; support audits and regulatory inspections.
- Lead validation studies/protocols and approve associated protocols and reports for analytical equipment and computer systems.
- Assist development of specification documentation to comply with validation standards and QMS methodologies.
- Develop/update computer system validation procedures/policies; monitor/update the Validation Master Plan per regulatory guidelines.
- Provide project leadership: priorities, timelines, deliverables, and cross-department resource coordination.
- Develop Validation Project Plans for major site changes and build team proficiency (e.g., analytical equipment qualification, computer system validation).
Basic Qualifications:
- 8+ years relevant technical experience; 5+ years hands-on validation in a regulated environment (equipment/facilities/utilities/computerized systems).
- Bachelor’s degree in engineering/life sciences/computer science (or related) or associate’s degree with 8+ years technical experience.
- Experience with Microsoft Windows configuration/settings, process control systems, databases; writing/executing IQ/OQ/PQ (or equivalent) validation protocols.
Preferred Qualifications:
- Advanced degree; experience leading projects/supervising small teams.
- Computerized system validation with lifecycle documentation and 21 CFR Part 11.
- Commissioning/qualification of utilities and automation systems.
- Lean/Six Sigma/continuous improvement training.
- Strong interpersonal skills and cross-functional stakeholder experience.
What we offer:
- Growth and visibility through high-impact projects and expansion of technical and leadership skills.
Application Instructions:
- Apply now and tell us how your experience can help the team move forward.
This role is responsible for understanding modern computer systems and control/digital systems within the facility and leading validation projects for equipment, facilities, utilities, and computerized systems. Responsibilities include writing/reviewing validation protocols, running/supervising testing, analyzing results, and authoring final reports with engineering, quality, operations, and IT.
Responsibilities:
- Lead validation test activities; plan, write, and execute validation protocols and final reports; collect/analyze data and resolve deviations.
- Coordinate cross-functional teams, vendors, and contractors; maintain validation project plans and the Site Validation Master Plan.
- Mentor junior validation staff; support audits and regulatory inspections.
- Lead validation studies/protocols and approve associated protocols and reports for analytical equipment and computer systems.
- Assist development of specification documentation to comply with validation standards and QMS methodologies.
- Develop/update computer system validation procedures/policies; monitor/update the Validation Master Plan per regulatory guidelines.
- Provide project leadership: priorities, timelines, deliverables, and cross-department resource coordination.
- Develop Validation Project Plans for major site changes and build team proficiency (e.g., analytical equipment qualification, computer system validation).
Basic Qualifications:
- 8+ years relevant technical experience; 5+ years hands-on validation in a regulated environment (equipment/facilities/utilities/computerized systems).
- Bachelor’s degree in engineering/life sciences/computer science (or related) or associate’s degree with 8+ years technical experience.
- Experience with Microsoft Windows configuration/settings, process control systems, databases; writing/executing IQ/OQ/PQ (or equivalent) validation protocols.
Preferred Qualifications:
- Advanced degree; experience leading projects/supervising small teams.
- Computerized system validation with lifecycle documentation and 21 CFR Part 11.
- Commissioning/qualification of utilities and automation systems.
- Lean/Six Sigma/continuous improvement training.
- Strong interpersonal skills and cross-functional stakeholder experience.
What we offer:
- Growth and visibility through high-impact projects and expansion of technical and leadership skills.
Application Instructions:
- Apply now and tell us how your experience can help the team move forward.