Validation Standards Manager

GSK; Hamilton (MT); On-site; USD 90,000 - 120,000; Full time

Job summary

GSK is seeking a Validation Lead at their manufacturing site in Hamilton, Montana. This role involves leading validation efforts to ensure compliance with regulatory standards for pharmaceuticals. Candidates should have a Bachelor's degree and over 8 years of validation experience, along with leadership skills.

Key responsibilities include developing Validation Master Plans, leading inspection efforts, and risk management. Join GSK in providing high-quality medicines and vaccines while ensuring effective validation processes.

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 validation engineers to deliver and maintain validation projects.
• Develop and maintain Validation Master Plans and protocols.
• Act as technical lead during regulatory inspections.
• Define validation requirements for engineering and quality partners.
• Identify high-risk validation areas and implement improvement standards.
• Support training for consistent validation practices across sites.

Skills

Pharmaceutical validation

Project management

Risk management

Technical supervision

Regulatory compliance

Education

Bachelor's degree in engineering or life sciences

Job description

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

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.

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.