Sierra Instrumentation

Position: Validation Engineer (Equipment's)

Location: Thane / On Site within India

Experience Required: 1-2 Years

Qualification: 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.