Principal Validation Engineer

Key Skills: Validation, Process Validation, System Validation, Equipment Qualification, cGMP, GxP, SOPs, CAPA, Risk Assessment, DOE, SPC, Cp/Cpk, Process Optimization, Quality Compliance

Roles & Responsibilities:

• Lead validation projects and develop validation strategies for process, system, and equipment qualification activities.
• Prepare, review, and maintain validation protocols, reports, and technical documentation in line with regulatory and quality requirements.
• Conduct risk assessments, investigate technical issues, and support CAPA actions using structured problem-solving methods.
• Apply statistical tools such as DOE, SPC, and Cp/Cpk to support process monitoring and improvement initiatives.
• Support compliance with cGMP, SOPs, and GxP requirements while driving continuous improvement in quality and efficiency.

Experience:

• 7 to 12 years of relevant validation experience in a regulated manufacturing environment.
• Hands-on validation experience across process, system, and equipment environments.
• Strong protocol and documentation capability for regulated manufacturing operations.
• Risk assessment and process optimization experience in a quality-driven setting.
• Ability to support compliance, technical problem solving, and data-based decision making.

Good to Have:

• Medical device or pharmaceutical manufacturing background.
• Experience with GxP validation practices and GxP compliance.
• Project management exposure in validation or quality programs.
• Experience preparing reports for regulated environments.

Education:

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related discipline.