Validation Professional
12 hours ago
Job Description:
We are seeking a skilled Validation Engineer to join our team at Sierra Instrumentation & Controls. This is an exciting opportunity for a dedicated professional to take on the challenge of ensuring the quality and compliance of our equipment validation processes.
About the Role:
This role involves performing validation activities for pharmaceutical equipment, including autoclaves, HVAC systems, cleanrooms, and other manufacturing/packaging equipment. The successful candidate will execute validation protocols as per industry standards and guidelines (GMP/GAMP, FDA, etc.) and ensure compliance with regulatory requirements and customer specifications.
Key Responsibilities:
- Validation Execution: Perform validation activities for pharmaceutical equipment, including autoclaves, HVAC systems, cleanrooms, and other manufacturing/packaging equipment.
- Protocol Development: Draft, review, and approve validation protocols and reports for new and existing equipment.
- Documentation and Compliance: Maintain detailed records of validation tests and results and ensure all validation activities meet quality standards and regulatory requirements.
- Problem-Solving: Identify, analyze, and resolve technical issues during validation and recommend improvements in equipment and validation processes.
- Cross-Functional Collaboration: Work closely with the Quality Assurance, R&D, Production, and Maintenance teams to support audits and inspections related to validation.
- Training: Train and mentor team members on validation principles, techniques, and tools.
Requirements:
To be successful in this role, you should have a strong understanding of validation principles, including IQ, OQ, and PQ, and familiarity with cGMP, GAMP, and FDA/EMEA regulations. You should also be proficient in using validation equipment (e.g., Kaye Validator) and possess good analytical and problem-solving skills.
Additional Requirements:
The ideal candidate will have experience in pharma plant automation and hold certification in validation or quality management. Willingness to travel to client sites as needed is also essential.
Salary: ₹12,00,000 - ₹18,00,000 per annum, depending on experience.
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