Job Title: Validation Engineer / Validation Executive

Job Summary

Key Responsibilities
- Perform qualification and validation activities for equipment, utilities, HVAC systems, cleanrooms, and computerized systems.
- Prepare, review, and execute IQ, OQ, and PQ protocols and reports.
- Conduct Air Flow Visualization (Smoke Studies) and Cleanroom Validation activities.
- Perform Environmental Monitoring and Cleanroom Performance Qualification studies.
- Support Computer System Validation (CSV) activities including URS, Risk Assessment, IQ/OQ/PQ, and Validation Reports.
- Prepare validation documentation including SOPs, Validation Plans, Traceability Matrices, and Summary Reports.
- Coordinate with clients, QA, Engineering, Production, and Maintenance departments.
- Ensure compliance with GMP, FDA, EU GMP, WHO, ISO, and other applicable regulatory requirements.
- Assist during audits, inspections, and regulatory assessments.
- Analyze validation data and prepare technical reports.
- Travel to client sites for execution of validation activities as required.

Qualification




- B.E./B.Tech / M.E./M.Tech in Mechanical, Chemical, Instrumentation, Electrical, Pharmaceutical Engineering, Biotechnology, or related field.

Experience
- Validation Executive: 0-3 years of experience.
- Validation Engineer: 2-5 years of experience.
- Experience in pharmaceutical, biotech, medical device, or healthcare projects preferred.

Required Skills:
- Equipment Qualification (IQ/OQ/PQ)
- HVAC Validation
- Cleanroom Validation
- Air Flow Visualization (Smoke Study)
- Environmental Monitoring
- Computer System Validation (CSV)
- GMP Documentation
- Risk Assessment
- Technical Report Writing
- Valuable Communication Skills
- MS Office (Word, Excel, PowerPoint)

Job Location
- Client Sites Across India
- Willingness to Travel Required

Employment Type
- Full-Time

Preferred Certifications
- GMP Training
- GAMP 5 Awareness
- ISO 14644 Awareness
- CSV Training (preferred)

Salary

Pay: ₹10,000.00 - ₹1

📌 Validation Engineer (Aurangabad)
🏢 Ayush Pharma and Engineering
📍 Aurangabad