Validation Standards Manager

GlaxoSmithKline; Montana; On-site; USD 90,000 - 120,000; Full time

Job summary

GlaxoSmithKline is seeking a leader to guide validation standards and provide technical expertise across a manufacturing network in the United States. The successful candidate will work closely with various departments to implement practical validation strategies and maintain compliance.

Key responsibilities include leading validation engineers, developing master plans, and acting as the technical lead during inspections. Candidates should have a Bachelor's degree and over 8 years of relevant experience. This position is on-site in Montana with potential travel for inspections and audits.

Qualifications

• 8+ years of pharmaceutical or biopharmaceutical validation experience.
• Experience leading or supervising technical teams.
• Experience authoring and executing validation protocols and plans.

Responsibilities

• Lead validation engineers and manage validation projects.
• Develop Validation Master Plans and related documentation.
• Act as technical lead during regulatory inspections.

Skills

Leadership

Validation expertise

Risk management

Technical guidance

Education

Bachelor's degree in engineering or life sciences

Advanced degree in related field

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. This role offers visible impact, leadership growth, and the chance to help unite science, technology, and talent to get ahead of disease together.

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.

Equal Opportunity Employer

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.