Sterilisation Validation Engineer Jobs in Coimbatore Medical Device Company

📋 Job Description

Jobzi is sourcing qualified candidates for Sterilisation Validation Engineer positions in Coimbatore's private Medical Device Company sector. This is a full-time opportunity with a reputed Medical Device and Equipment 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

• Plan and execute sterilisation validation studies for medical devices using EO, gamma, or steam methods per ISO 11135 and ISO 11137
• Write validation protocols, execute studies, and compile validation reports with statistical SAL 10-6 evidence
• Coordinate bioburden testing, biological indicator monitoring, and dose audit studies with accredited labs
• Perform packaging integrity validation including seal strength, dye penetration, and microbial barrier testing
• Maintain sterilisation cycle records, load configuration logs, and ongoing efficacy monitoring data
• Support revalidation activities triggered by product or process changes
• Prepare sterilisation sections of regulatory technical files for CDSCO and CE submissions

🎓 Qualifications and Requirements

• Which sterilisation methods have you validated - EO, gamma, steam, or e-beam?
• Have you written and executed sterilisation validation protocols per ISO 11135 or ISO 11137?
• Are you familiar with SAL 10-6 requirements and how bioburden influences dose selection?
• Have you coordinated with contract sterilisation facilities for device sterilisation?
• What is your experience with packaging integrity testing for sterile devices?
• Have you supported sterilisation revalidation due to product or process changes?
• Have you contributed sterilisation validation data to a regulatory submission?
• Good Tamil and English communication skills for team coordination and client interaction in Coimbatore.

✅ Required Skills

🏆 Certifications and Qualifications

B.E./B.Tech. (Biomedical, Mechanical, or Electronics) for engineering and field service roles; M.Sc. or B.Sc. in Life Sciences for IVD application and quality roles; ISO 13485 quality management system training; CDSCO MDR 2017 regulatory compliance knowledge for regulatory affairs roles; IEC 60601 and CE marking awareness for quality roles; Lean Manufacturing and GMP training for production roles; BLS and medical device demonstration certification for clinical sales specialists