
Process Engineer
- Bangalore, Karnataka
- Permanent
- Full-time
- Be the primary lead for defining and executing installation and validation processes for new or existing equipment and products in compliance with company standards, IVD regulations and GMP standards.
- Plan & execute documentation as per QMS requirements, including preparation, writing, and filing of validation plans, SOPs, protocols and reports.
- Apply knowledge of relevant continuous improvement tools and approaches to increase production up-time, minimize unplanned maintenance, minimize work in process inventories (WIP) or plant inventories, and implement cost reduction initiatives across equipment and labor.
- Bachelors or master’s in biotechnology or related engineering fields with Minimum 2 years of experience in manufacturing, preferably in Medical Device/ IVD sectors.
- Strong background in equipment and product validation for medical device manufacturing. Understanding of mechanical design concepts and machinery: mixing processes, motors, pumps, vacuum, and hydraulics.
- Experience of working in a regulated work environment (ISO, GMP, Medical Device regulations)