Senior Validation Engineers directly create, implement, execute and support the validation strategy at use at the GSK Hamilton Site ensuring it is harmonized with local, regulatory, and GSK standards.
They manage, schedule, coordinate and execute assigned qualification or validation activities to ensure timely completion of the Validation Plan in coordination with the User, Technical Services, Quality Control, Quality Assurance and Regulatory departments.
Finally, they support maintaining all process and laboratory equipment, facilities, and critical systems/utilities at Hamilton site in a validated state.
• Develop the site qualification plan and strategy, execution and implementation. Streamline testing requirements while maintaining regulatory and corporate compliance including creating new validation approaches for new equipment, processes, or to align procedures and standards
• Develop, review, approve, and/or manage GxP system lifecycle documentation including Validation Plans, User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Traceability Matrix, Validation Reports, SOPs, Change Control Documentation, Risk Assessments, Validation Deviations and Qualification Summary Reports
• Conduct System Compliance Risk Assessment
• Generation, maintenance, technical review and approval of standard operational procedures for validation activities and site standard operating procedures.
• Assess impact of changes to cGMP equipment/systems and methods and establish the applicable validation plan to ensure validated status following changes. Issue QSR confirming validation plan was successfully completed.
• Support for internal audits, external global audits, regulatory agency audits and system compliance risk assessments as subject matter expert in assigned validation discipline.
• Responsible for scheduling, managing, executing and approving Periodic Validation Review activities
• Maintain up to date knowledge of validation requirements, practices and procedures and instruct other members of the site participating in validation studies
• Work with other departments to troubleshoot equipment, process and validation issues.
• Perform all job responsibilities in compliance with applicable EHS and GMP regulation, guidelines, policies and standard operating procedures.
• Administer and create the computer validation program for the site, including the author/review/approval of computer Validation Master Plans, Process control installation/operational qualification protocols, alarm acceptance testing, computer acceptance testing protocols and maintenance of computer systems in accordance with corporate and departmental procedures.
• Acts as a Multi-Site Validation (MSV) SME for computer systems.
• Acts as Computer Systems SME during audits and assessments.
• Reviewing completed protocols for completeness, cGxP compliance and data acceptability
• Bachelors degree
• 5 years of validation experience in Computer or Automated systems validation in a Pharmaceutical or related industry.
• Demonstrated competence in Computer Systems or Automated Systems Validation and awareness of 2 or more elements of validation including but not limited to:
• Equipment Qualification (DQ/IQ/OQ/CAT/AAT)
• Cleaning Validation
• Steam Sterilization
• Dry Heat depyrogenation
• Environmental Monitoring
• Clean Utilities Qualification
• Process Validation
• Validation of Aseptic Processing
• HVAC, Smoke Studies, and EM Qualification
• Method Validation
• Single Use Systems
• BS in Engineering or Computer Science
• Certified Project Management Professional
• Certified Quality Engineer
• Certified Six Sigma Engineer
• ASQ or equivalent Black Belt
• ASQ or equivalent Green Belt
• Use and understanding of SAP system.
Why GSK? Because GSK’s vaccines business puts the customer at the heart of everything we do. That’s why we define our vaccines mission as: Protecting • Human • Kind. Protecting because we strive to turn the science of immunology into high-quality, practical protection against disease; Human because we are investing time in understanding and delivering on our customers’ needs and helping them achieve their vaccination goals; and Kind because we recognize and act on our responsibilities to serve societies, rich and poor.
You may apply for this position online by selecting the Apply now button.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.