Validation Engineer Jobs in Coimbatore Pharmaceutical Company

📋 Job Description

Jobzi is sourcing qualified candidates for Validation Engineer positions in Coimbatore's private Pharmaceutical Company sector. This is a full-time opportunity with a reputed Pharmaceutical and Life Sciences employer in Coimbatore offering competitive salary, structured growth, and a professional work environment. Tamil communication skills are preferred alongside English for professional and business interaction in Coimbatore.

📌 Key Responsibilities

• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment and utilities
• Prepare and review validation protocols, reports, and summary documents for GMP compliance
• Conduct process validation for solid dosage, liquid, and sterile manufacturing operations
• Perform Computer System Validation (CSV) for pharma software and automated equipment per GAMP 5
• Execute cleaning validation studies and prepare cleaning validation protocols per regulatory guidance
• Support regulatory inspection preparation by maintaining complete validation lifecycle documentation
• Review change controls and assess validation impact for equipment modifications and process changes

🎓 Qualifications and Requirements

• B.Pharm, B.E. in Mechanical, Chemical, or Instrumentation Engineering from a recognized university
• 2 - 6 Years of pharma validation experience (equipment qualification and/or process validation)
• Knowledge of IQ/OQ/PQ protocols, GMP requirements, and FDA/EU GMP validation guidance
• Experience with CSV validation per GAMP 5 for automated systems and laboratory instruments
• Ability to prepare validation protocols, deviation reports, and summary documents
• Understanding of risk assessment tools (FMEA, risk matrices) for validation lifecycle
• Attention to regulatory compliance requirements for USFDA, EU GMP, and CDSCO submissions
• Good Tamil and English communication skills for team coordination and client interaction in Coimbatore.

✅ Required Skills

🏆 Certifications and Qualifications

B.Pharm, M.Pharm, M.Sc Life Sciences, MBBS, BDS, Ph.D. in Pharmaceutical Sciences, ICH GCP certification, Drug Safety certification (ISoP), CCRP (Clinical Research), RAPS certification (Regulatory Affairs)