Validation Standards Lead - Pharma & Biopharma Quality

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

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.