This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Generation, maintenance, and technical review of standard operational procedures for validation activities and site standard operating procedures.
• Responsible for executing Periodic Validation Review activities
• Support all aspects of the validation life cycle from design through operation, improvement, and retirement.
• Administer the computer validation program for the site, including the creation/review/execution/approval of, 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.
• Develop, review, execute, 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 Validation Summary Reports with Value Stream, Technical Services, Quality Control, Quality Assurance and Regulatory departmental representatives.
• Perform all job responsibilities in compliance with applicable EHS and GMP regulation, guidelines, policies, and standard operating procedures.
• Work with other departments to troubleshoot equipment, process, and validation issues such as deviation impact assessments and root cause analysis.
• Maintain up-to-date knowledge of validation requirements, practices, and procedures
• Support Validation SME in internal, external global and regulatory agency audits and system compliance risk assessments.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree in any Discipline
• 2+ years experience in Pharmaceutical industry or other regulated industry

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Filtration
• Certified Project Management Professional
• Technical writing organizational, communication and team skills.
• Filtration
• Environmental Monitoring
• Dry Heat depyrogenation
• BS in programming related Engineering or Science Field (i.e. Software Engineer)
• ASQ or equivalent Green Belt
• Cleaning Validation
• ASQ or equivalent Black Belt
• Clean Utilities Qualification
• Equipment Qualification (DQ/IQ/OQ/CAT/AAT)
• Ability to work on multiple projects, ability to prioritize and flexibility to adapt to changing priorities.
• SAP experience
• Use and understanding of SAP system.
• Validation of Aseptic Processing
• HVAC, Smoke Studies, and EM Qualification
• Certified Six Sigma Engineer
• Certified Quality Engineer
• Steam Sterilization

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Get Ahead Together

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