Validation Standards Manager

GlaxoSmithKline; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

GSK is seeking a senior validation professional to lead validation across a U.S. manufacturing network. The role partners with engineering, manufacturing, quality, and regulatory teams to set practical validation strategies, maintain validated states, and support inspections.

You will coach validation engineers, oversee protocols and master plans, and act as the technical lead during inspections to ensure regulatory compliance and efficient validation practices.

Qualifications

• 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.

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 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.

Skills

Leadership

Validation protocols

Regulatory inspections

Education

Bachelor's degree in engineering

Advanced degree (engineering/science)

Job description

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.

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 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

• 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

• 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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.