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.
- Robust 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.

📌 Principal Validation Engineer (Bengaluru)
🏢 Careernet
📍 Bengaluru