Job Title: Validation Engineer / Validation Executive
Job Summary
We are seeking a motivated Validation Engineer / Validation Executive to support qualification and validation activities for pharmaceutical, biotechnology, healthcare, and regulated manufacturing facilities. The candidate will be responsible for executing validation protocols, preparing documentation, and ensuring compliance with GMP, regulatory requirements, and industry standards.
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.
- B.Pharm / M.Pharm candidates may also apply.
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
- Good Communication Skills
- MS Office (Word, Excel, PowerPoint)
Job Location
- Client Sites Across India
- Willingness to Travel Required
Employment Type
Preferred Certifications
- GMP Training
- GAMP 5 Awareness
- ISO 14644 Awareness
- CSV Training (Preferred)
Salary
As per industry standards and candidate experience.
Pay: ₹10,000.00 - ₹15,000.00 per month
Benefits:
Work Location: Remote
