Process Engineer

Beckman Coulter; Bengaluru; On-site; INR 6,00,000 - 10,00,000; Full time

Job summary

An established industry player is seeking a skilled Process Engineer to enhance manufacturing processes within the medical device sector. This role offers the chance to lead the installation and validation of equipment, ensuring compliance with industry regulations. You will utilize your expertise in continuous improvement to drive efficiency and optimize production outcomes. Join a dynamic team dedicated to making a real-world impact through innovative diagnostic solutions. If you're passionate about engineering and eager to contribute to transformative healthcare advancements, this opportunity is perfect for you.

Qualifications

• 2+ years of experience in manufacturing, preferably in Medical Device/IVD sectors.
• Strong background in equipment and product validation for medical device manufacturing.

Responsibilities

• Lead installation and validation processes for equipment and products.
• Apply continuous improvement tools to increase production up-time and reduce costs.

Skills

Continuous Improvement

Problem Solving

Equipment Validation

Process Knowledge

Education

Bachelor's in Biotechnology

Master's in Biotechnology

Tools

QMS Documentation

ISO Standards

GMP Standards

Job description

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

The Process Engineer is responsible for developing a strategy and executing a plan to deliver continuous process performance improvements related to Safety, Quality, Delivery, and Cost of a manufacturing process or line. The Process Engineer will work with continuous improvement initiatives and be responsible for overall equipment/process performance and executing equipment/process validations, including efficiency tracking and problem solving. The Process Engineer will also leverage process knowledge to identify opportunities/solutions to improve throughput capacity by reducing the impact of constraints.

This position is part of Cepheid’s MII Bangalore Plant and will be located in Mahadeva Kodigehalli, Bangalore.

In this role, you will have the opportunity to:

1. 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.
2. Plan and execute documentation as per QMS requirements, including preparation, writing, and filing of validation plans, SOPs, protocols, and reports.
3. Apply knowledge of relevant continuous improvement tools and approaches to increase production up-time, minimize unplanned maintenance, minimize work in process inventories (WIP), and implement cost reduction initiatives across equipment and labor.

The essential qualifications/requirements of the job include:

1. Bachelor's or Master's in biotechnology or related engineering fields with a minimum of 2 years of experience in manufacturing, preferably in Medical Device/IVD sectors.
2. 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.
3. Experience working in a regulated work environment (ISO, GMP, Medical Device regulations).

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.