Senior Validation Engineer

3 weeks ago

Chennai India Tek Support Full time

Job Description Job Title:Senior Trainer Validation (CQV, Equipment, Injection Mold, HVAC) Location: Remote Job type: Part-time Job Summary: To design, develop, and deliver comprehensive training programs on Commissioning, Qualification & Validation (CQV), Equipment Qualification, Injection Molding Process Validation, and HVAC System Validation. The trainer will ensure technical competency development across engineering and quality teams in compliance with international regulatory standards (USFDA, EU GMP, ISO 13485, etc.). Key Responsibilities: - Develop and deliver training modules on: - Commissioning, Qualification, and Validation (CQV) lifecycle - Equipment Qualification (IQ/OQ/PQ) - Process Validation for Injection Molding Machines - HVAC system qualification and cleanroom validation - Design hands-on practical sessions, assessments, and workshops to enhance applied learning. - Review and update training materials as per the latest regulatory and industry standards. - Conduct competency assessments and provide feedback to trainees and management. - Collaborate with validation, quality assurance, and engineering departments to align training needs with current and future project requirements. - Support in developing SOPs, validation protocols, and templates for training use. - Monitor training effectiveness using evaluation metrics (KPI / feedback analysis). - Ensure all training complies with GMP, ISO, and EHS standards. - Mentor junior validation engineers and guide them in real-time project scenarios. Key Skills and Competencies: - Strong knowledge of CQV methodologies, GAMP 5, Risk-Based Validation, and Change Control. - Expertise in Equipment & Utility Qualification, Injection Molding Validation, and HVAC System Validation. - Familiarity with regulatory frameworks: USFDA, EMA, WHO, ISO 13485, ISO 14644. - Excellent presentation, communication, and technical documentation skills. - Ability to translate complex validation concepts into practical training modules. - Proficient in Microsoft Office, validation software, and data analysis tools. Educational Qualification: - Bachelor's or Master's degree in Mechanical / Electrical / Instrumentation / Industrial / Validation Engineering or related discipline. - Additional certification in Validation / Quality Systems / Six Sigma (preferred).

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