Validation Standards Manager
GSK
17 days ago
On-site
Hamilton, MT
IT
Position Summary:
You will lead validation standards and provide technical expertise across a manufacturing network in the United States, partnering with engineering, manufacturing, quality, and regulatory colleagues to set validation strategies, maintain validated states, and support inspections.
Responsibilities:
- Lead and coach validation engineers/SMEs 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 aligned with regulatory expectations and efficient practices.
- Act as technical lead during regulatory inspections; support inspection preparation, responses, and post-inspection remediation.
- Define validation requirements and provide practical guidance to cross-functional 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:
On-site at 553 Old Corvallis Road, Hamilton, Montana, 59840, USA. Some travel may be required.
Basic Qualifications:
- Bachelor’s degree in engineering, life sciences, or related technical discipline.
- 8+ years of pharmaceutical/biopharmaceutical validation experience.
- Experience leading/supervising technical teams.
- Experience authoring and executing validation protocols and plans.
Preferred Qualifications:
- Advanced degree.
- Cleaning validation, process validation lifecycle, or computerized system validation experience.
- Sterile manufacturing or large-scale drug substance/drug product experience.
- Participation in regulatory inspections/audit response.
- Project/risk management certification or experience.
- Matrix organization experience and coaching diverse teams.
How To Apply:
Apply with your resume and a brief note describing a recent validation challenge you led and the outcomes.
You will lead validation standards and provide technical expertise across a manufacturing network in the United States, partnering with engineering, manufacturing, quality, and regulatory colleagues to set validation strategies, maintain validated states, and support inspections.
Responsibilities:
- Lead and coach validation engineers/SMEs 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 aligned with regulatory expectations and efficient practices.
- Act as technical lead during regulatory inspections; support inspection preparation, responses, and post-inspection remediation.
- Define validation requirements and provide practical guidance to cross-functional 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:
On-site at 553 Old Corvallis Road, Hamilton, Montana, 59840, USA. Some travel may be required.
Basic Qualifications:
- Bachelor’s degree in engineering, life sciences, or related technical discipline.
- 8+ years of pharmaceutical/biopharmaceutical validation experience.
- Experience leading/supervising technical teams.
- Experience authoring and executing validation protocols and plans.
Preferred Qualifications:
- Advanced degree.
- Cleaning validation, process validation lifecycle, or computerized system validation experience.
- Sterile manufacturing or large-scale drug substance/drug product experience.
- Participation in regulatory inspections/audit response.
- Project/risk management certification or experience.
- Matrix organization experience and coaching diverse teams.
How To Apply:
Apply with your resume and a brief note describing a recent validation challenge you led and the outcomes.