Senior Validation Engineer
GSK
August 11, 2026
On-site
King of Prussia, PA
Operations
Position Summary:
This role is 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. Serve as a leading team member representing Validation on project teams.
Responsibilities:
- Lead validation test activities; collect and analyze data; resolve deviations. Plan, write, and execute validation protocols and final reports for equipment, utilities, facilities, and computerized systems.
- Coordinate cross-functional teams, vendors, and contractors to meet timelines; maintain and update validation project plans and the Site Validation Master Plan.
- Mentor and coach junior validation staff. Support audits and regulatory inspections via documentation and responses to findings.
- Oversee validation studies/protocols for analytical equipment and computer systems; lead approval of protocols and associated reports.
- Assist specification documentation development to comply with current validation standards and QMS methodologies.
- Develop and maintain computer system validation procedures/policies; monitor and update the Validation Master Plan per regulatory guidelines.
- Lead prioritization, timelines, and tracking; ensure deliverables are met; coordinate resources with other departments.
- 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 experience in a regulated environment (equipment, facility, utilities, or computerized systems).
- Bachelor’s degree in engineering/life sciences/computer science (or related) or associate’s in engineering/life sciences/biology with 8+ years technical experience.
- Experience with hardware/software (Microsoft Windows settings/configuration), process control systems, databases; writing/executing IQ/OQ/PQ (or equivalent) validation protocols.
Preferred Qualifications:
- Advanced degree.
- Experience leading projects/supervising small technical teams.
- Computerized system validation experience (including lifecycle documentation and 21 CFR Part 11).
- Commissioning/qualification experience for utilities and automation systems.
- Training in Lean, Six Sigma, or continuous improvement.
- Strong interpersonal skills; cross-functional stakeholder experience.
Work Arrangement:
- Completely onsite (no hybrid or work-from-home).
Application Instructions:
- Apply now and tell how your experience can help the team move forward.
This role is 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. Serve as a leading team member representing Validation on project teams.
Responsibilities:
- Lead validation test activities; collect and analyze data; resolve deviations. Plan, write, and execute validation protocols and final reports for equipment, utilities, facilities, and computerized systems.
- Coordinate cross-functional teams, vendors, and contractors to meet timelines; maintain and update validation project plans and the Site Validation Master Plan.
- Mentor and coach junior validation staff. Support audits and regulatory inspections via documentation and responses to findings.
- Oversee validation studies/protocols for analytical equipment and computer systems; lead approval of protocols and associated reports.
- Assist specification documentation development to comply with current validation standards and QMS methodologies.
- Develop and maintain computer system validation procedures/policies; monitor and update the Validation Master Plan per regulatory guidelines.
- Lead prioritization, timelines, and tracking; ensure deliverables are met; coordinate resources with other departments.
- 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 experience in a regulated environment (equipment, facility, utilities, or computerized systems).
- Bachelor’s degree in engineering/life sciences/computer science (or related) or associate’s in engineering/life sciences/biology with 8+ years technical experience.
- Experience with hardware/software (Microsoft Windows settings/configuration), process control systems, databases; writing/executing IQ/OQ/PQ (or equivalent) validation protocols.
Preferred Qualifications:
- Advanced degree.
- Experience leading projects/supervising small technical teams.
- Computerized system validation experience (including lifecycle documentation and 21 CFR Part 11).
- Commissioning/qualification experience for utilities and automation systems.
- Training in Lean, Six Sigma, or continuous improvement.
- Strong interpersonal skills; cross-functional stakeholder experience.
Work Arrangement:
- Completely onsite (no hybrid or work-from-home).
Application Instructions:
- Apply now and tell how your experience can help the team move forward.