Sierra Instrumentation

Position: Validation Engineer (Equipment's)Location: Thane / On Site within IndiaExperience Required: 1-2 YearsQualification: BE Instrumentation, Diploma / ITI Instrumentation

Validation Execution:Perform validation activities for pharmaceutical equipment, including autoclaves, HVAC systems, cleanrooms, and other manufacturing/packaging equipment.Execute validation protocols as per industry standards and guidelines (GMP/GAMP, FDA, etc.).

Protocol Development:Draft, review, and approve validation protocols and reports for new and existing equipment.Ensure compliance with regulatory requirements and customer specifications.

Documentation and Compliance:Maintain detailed records of validation tests and results.Ensure all validation activities meet quality standards and regulatory requirements (e.g., FDA, EU GMP, WHO).Prepare Standard Operating Procedures (SOPs) and validation documentation.

Problem-Solving:Identify, analyze, and resolve technical issues during validation.Recommend improvements in equipment and validation processes.

Cross-Functional Collaboration:Work closely with the Quality Assurance, R&D, Production, and Maintenance teams.Support audits and inspections related to validation.

Training:Train and mentor team members on validation principles, techniques, and tools.

Skills Required:Strong understanding of validation principles, including IQ, OQ, and PQ.Familiarity with cGMP, GAMP, and FDA/EMEA regulations.Proficiency in using validation equipment (e.g., Kaye Validator).Good analytical and problem-solving skills.Excellent communication and documentation skills.Ability to handle multiple projects and work under pressure.

Additional Requirements:Willingness to travel to client sites as needed.Experience in pharma plant automation is a plus.Certification in validation or quality management is advantageous.

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