Senior Validation Standards Lead – Pharma Manufacturing

Biopharma Careers; Kentucky; On-site; USD 110,000 - 150,000; Full time

Job summary

GSK in the United States seeks a senior validation leader to set practical validation strategies across a manufacturing network. You will lead validation engineers, partner with engineering, manufacturing, quality and regulatory colleagues, and guide inspections with risk-based judgment and clear decision making.

This role offers visible impact, leadership growth, and the chance to advance smart manufacturing technologies, including robotics, digital solutions, and computerized systems, to

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

Validation engineering

Team leadership

Regulatory inspections

Validation protocols

Risk management

Education

Bachelor's degree in engineering or life sciences

Advanced degree preferred

Job description

GSK in the United States seeks a senior validation leader to set practical validation strategies across a manufacturing network. You will lead validation engineers, partner with engineering, manufacturing, quality and regulatory colleagues, and guide inspections with risk-based judgment and clear decision making.

This role offers visible impact, leadership growth, and the chance to advance smart manufacturing technologies, including robotics, digital solutions, and computerized systems, to