Staff MES Solutions Engineer

3 weeks ago

India Danaher Full time
Job Description

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology

At Cepheid, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world's most complex health challenges. Together, we bring MORE change to the world.

TheStaff MES Solutions EngineerMES (Manufacturing Execution System) to lead and support change initiatives within our MES environment. This role is critical in ensuring that system updates, enhancements, and process changes are implemented smoothly, efficiently, and with minimal disruption to manufacturing operations. The ideal candidate will have a strong background in MES systems, change control processes, a strong understanding of good manufacturing practices (GMP), and cross-functional collaboration.

This position reports to the Principle Solutions Architect and is part of the Systems Engineering group located in India and will be an on-site role.

In this role, you will have the opportunity to:

- Coordinate and manage MES non-standard change requests through work intake, including impact assessments, risk analysis, and stakeholder approvals.

- Develop and maintain change management documentation (process maps, solution designs, component designs, validation plans, test scripts, UATs, and SOPs).

- Collaborate with IT, Quality, Manufacturing, and Engineering teams to ensure successful implementation of MES changes.

- Ensure compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, GMP) and internal quality standards.

- Support MES configuration, testing, validation, and deployment activities.

The essential requirements of the job include:

- Bachelor's degree in Engineering, Computer Science, Information Systems, or related field.

- 8+ years of experience in MES systems (e.g., Werum PAS-X, Rockwell PharmaSuite, Siemens Opcenter).

- Strong understanding of change management principles and methodologies.

- Experience in regulated manufacturing environments (pharma, biotech, medical devices, etc.).

- Familiarity with GxP, GMP, and validation practices.

- Excellent communication, documentation, and project management skills.

- Ability to work independently and collaboratively in a fast-paced environment.

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.

For more information, visit .

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