Validation Engineers directly 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 under the supervision of SME 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.

Key Responsibilities:

• Support all aspects of the validation life cycle from design through operation, improvement and retirement.
• Develop, review, approve, and managing GxP system lifecycle documentation with support from experienced Validation Experts, 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 with Value Stream, Technical Services, Quality Control, Quality Assurance and Regulatory departmental representatives.
• Support Validation SME in internal, external global and regulatory agency audits and system compliance risk assessments.
• Generation, maintenance, and technical review of standard operational procedures for validation activities and site standard operating procedures.
• Responsible for executing Periodic Validation Review activities
• Maintain up to date knowledge of validation requirements, practices and procedures
• Work with other departments to troubleshoot equipment, process and validation issues such as deviation impact assessments and root cause analysis.
• Perform all job responsibilities in compliance with applicable EHS and GMP regulation, guidelines, policies and standard operating procedures.
• Support the Multi-Site Validation (MSV) SME in Equipment Qualification.
• Support Equipment Qualification-Clean Systems (Autoclaves, Oven, Cleaning, Clean Utilities, Environmental, Filtration, etc.)
• Supports the site qualification, requalification and continuous monitoring plan (autoclaves, oven, cleaning, etc.)
• Supports the systems SME during audits.
• Coordinates and supports validation and qualification activities (DQ/IQ/OQ). Authors, reviews, and approves protocols and provides training on protocol execution.
• Reviewing executed protocols for completeness, cGxP compliance, data acceptability and data integrity/validation SME for impact assessments and root cause analysis for Deviations , Corrective Action/Preventative Action Reports, Outlier Reports, and assist with other investigations (OOT, etc.) related to clean systems.

Why You?Basic qualifications:

• Bachelors degree
• 1 year of experience in pharmaceuticals or a closely related industry
• Demonstrated awareness of 3 or more elements of validation including but not limited to:
• Computer systems
• Equipment Qualification (DQ/IQ/OQ/CAT/AAT)
• Cleaning Validation
• Steam Sterilization
• Dry Heat depyrogenation
• Filtration
• Environmental Monitoring
• Clean Utilities Qualification
• Process Validation
• Validation of Aseptic Processing
• Automation Qualification
• HVAC, Smoke Studies, and EM Qualification
• Method Validation
• Filtration
• Single Use Systems

Preferred qualifications:

• Bachelors in Engineering
• 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?:

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 man nd. 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.

Contact information:

You may apply for this position online by selecting the Apply now button.

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