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Validation Engineer

3 months ago

Hamilton, Montana, United States GlaxoSmithKline Full time

Site Name:
USA - Montana - Hamilton

Posted Date:
May
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
Experience in Pharmaceutical or regulated industry

Preferred Qualifications:
Bachelor's Degree in Science or Engineering
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.
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GSK US Benefits Summary

t o learn more about the comprehensive benefits program GSK offers US employees.
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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).

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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.
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