Validation Standards Manager
GSK
July 02, 2026
On-site
Hamilton, MT
Operations
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.
Responsibilities
- 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 reflecting regulatory expectations and efficient practices.
- Act as technical lead during regulatory inspections; 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
- On-site at 553 Old Corvallis Road, Hamilton, Montana, 59840, USA. Some travel may be required.
Basic Qualifications
- Bachelor’s degree in engineering, life sciences, or 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 Qualifications
- Advanced degree.
- Experience in cleaning validation, process validation lifecycle, or computerized system validation.
- Experience in sterile manufacturing or large-scale drug substance/product environments.
- Prior regulatory inspection or audit response experience.
- Certification/demonstrated experience in project management or risk management.
- Matrix organization experience and coaching diverse teams.
How to Apply
- Apply with your resume and a brief note describing a recent validation challenge you led and the outcomes.
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.
Responsibilities
- 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 reflecting regulatory expectations and efficient practices.
- Act as technical lead during regulatory inspections; 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
- On-site at 553 Old Corvallis Road, Hamilton, Montana, 59840, USA. Some travel may be required.
Basic Qualifications
- Bachelor’s degree in engineering, life sciences, or 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 Qualifications
- Advanced degree.
- Experience in cleaning validation, process validation lifecycle, or computerized system validation.
- Experience in sterile manufacturing or large-scale drug substance/product environments.
- Prior regulatory inspection or audit response experience.
- Certification/demonstrated experience in project management or risk management.
- Matrix organization experience and coaching diverse teams.
How to Apply
- Apply with your resume and a brief note describing a recent validation challenge you led and the outcomes.