Position Summary
You will lead validation standards and provide technical expertise across a manufacturing network in the United States. You will partner with engineering, manufacturing, quality and regulatory colleagues to set practical validation strategies, maintain validated states, and support inspections. We value clear decision makers who coach others, use risk-based judgment, and simplify complex problems. This role offers visible impact, leadership growth, and the chance to help unite science, technology, and talent to get ahead of disease together.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Lead and coach validation engineers and subject matter experts to deliver validation projects and maintain validated states for equipment, utilities, cleaning and computerized systems.
- Develop and maintain Validation Master Plans, validation protocols and validation reports that reflect regulatory expectations and efficient practices.
- Act as technical lead during regulatory inspections and support preparation, responses and post-inspection remediation.
- Define validation requirements and provide practical guidance to engineering, manufacturing, quality and regulatory partners.
- Identify high-risk validation areas and implement standards, templates, metrics and continuous improvements to reduce risk.
- Support training, tools and the validation community to enable consistent, scalable validation across sites.
Work Location
- This role is on-site at a United States manufacturing location: 553 Old Corvallis Road, Hamilton, Montana, 59840, USA . Some travel may be required for inspections, audits and cross-site collaboration.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor's degree in engineering, life sciences, or a related technical discipline.
- 8+ years of pharmaceutical or biopharmaceutical validation experience.
- Experience leading or supervising technical teams.
- Experience authoring and executing validation protocols and plans.
Preferred Qualification
If you have the following characteristics, it would be a plus:
- Advanced degree in engineering, science, or a related field.
- Experience in cleaning validation, process validation lifecycle, or computerized system validation.
- Experience in sterile manufacturing or large-scale drug substance or drug product environments.
- Previous participation in regulatory inspections or audit response activities.
- Certification or demonstrated experience in project management or risk management.
- Experience working within a matrix organization and coaching diverse teams.
How to apply
If this role feels like the next step for your career, please apply. Share your resume and a brief note describing a recent validation challenge you led and the outcomes. We welcome applicants from all backgrounds and value inclusion. Join us to grow your career and make a meaningful impact on health. Please visit [_GSK US Benefits Summary_](http://us.gsk.com/media/7992/ustrataglance-jobpostings.pdf) to learn more about the comprehensive benefits program GSK offers US employees.
