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Validation Engineer
Location:
Hamilton, MT
Description:
The Validation Engineer will 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.This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Support all aspects of the validation life cycle from design through operation, improvement, and retirement. 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. 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. 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 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. 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: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree 2+ years of Cleaning Validation Engineer experience Experience in Pharmaceutical or regulated industry Preferred Qualifications: Experience in Clean Systems Qualification (CIP, SIP, Autoclave, Oven, etc.) Demonstrated awareness of 3 or more elements of validation including but not limited to: Equipment Qualification (DQ/IQ/OQ/CAT/AAT), Cleaning Validation, Steam Sterilization, Dry Heat depyrogenation, Filtration, Environmental Monitoring, Clean Utilities Qualification, Validation of Aseptic Processing, HVAC, Smoke Studies, and EM Qualification, Filtration. Ability to take initiative and work proactively with creative problem solving skills. Adept at working both as an individual and in varying groups in a dynamic, multi-tasking environment. Ability to work on multiple projects, ability to prioritize and flexibility to adapt to changing priorities. Technical writing organizational, communication and team skills. 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. #LI-GSK#LI-Onsite#secondshiftPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. 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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).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 Ahead Together.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-XXXX (US Toll Free) or +1 801 567 XXXX (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.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.PDN-9c1fed5c-84af-4d33-97ae-73b4a76ad28e
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More About this Listing: Validation Engineer
Validation Engineer is a Engineering Validation Engineer Job at GSK located in Hamilton MT. Find other listings like Validation Engineer by searching Oodle for Engineering Validation Engineer Jobs.
Validation Engineer is a Engineering Validation Engineer Job at GSK located in Hamilton MT. Find other listings like Validation Engineer by searching Oodle for Engineering Validation Engineer Jobs.