11 Sep
|
MyCareernet
|
Bengaluru
11 Sep
MyCareernet
Bengaluru
Company:A Large Global Organization
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_103168 (Bengaluru)
🏢 MyCareernet
📍 Bengaluru