Maintenance Engineer – Medical Devices

Stark Pharma Solutions Inc; Sultanpur; Sur place; INR 500 000 - 700 000; Plein temps

Résumé du poste

Stark Pharma Solutions Inc is seeking a Maintenance Engineer to support ETO sterilization operations and maintain equipment within a medical device manufacturing environment. This role ensures equipment reliability and regulatory compliance while minimizing downtime in production operations.

The ideal candidate holds a Diploma/Degree in an engineering discipline with at least 2 years of experience in maintenance, specifically in the medical device or pharmaceutical field.

Strong troubleshooting and problem-solving skills are essential, along with knowledge of relevant regulatory standards.

Qualifications

• Minimum 2 years of experience in maintenance, sterilization, or medical device/pharmaceutical manufacturing.
• Knowledge of regulatory standards like ISO 13485 and ISO 11135.

Responsabilités

• Operate and monitor ETO sterilization equipment and processes.
• Perform preventive, predictive, and corrective maintenance on production and utility equipment.
• Support equipment calibration, validation, and qualification activities.

Connaissances

Troubleshooting

Documentation

Problem-solving

Knowledge of ETO sterilization

Formation

Diploma/Degree in Mechanical, Chemical, Biomedical Engineering, or related field

Description du poste

Position

Maintenance Engineer – Medical Devices (ETO Sterilization) – Location: Hyderabad – Experience: 2+ years.

Job Summary

We are seeking a Maintenance Engineer to support ETO sterilization operations and equipment maintenance within a medical device manufacturing environment. The role ensures equipment reliability, regulatory compliance, and smooth production operations.

Key Responsibilities

• Operate and monitor ETO sterilization equipment and processes.
• Perform preventive, predictive, and corrective maintenance on production and utility equipment.
• Monitor sterilization parameters and maintain accurate documentation.
• Support equipment calibration, validation, and qualification activities.
• Troubleshoot equipment issues and minimize downtime.
• Ensure compliance with ISO 13485, ISO 11135, GMP, and safety requirements.
• Support audits, investigations, CAPAs, and continuous improvement initiatives.

Qualifications

• Diploma/Degree in Mechanical, Chemical, Biomedical Engineering, or related field.
• 2+ years of experience in maintenance, sterilization, or medical device/pharmaceutical manufacturing.
• Knowledge of ETO sterilization, GMP, ISO 13485, and ISO 11135 preferred.
• Strong troubleshooting, documentation, and problem‑solving skills.