The Scientist I – Validation is responsible for ensuring validation and release of equipment and / or Instrument along with the associated software as applicable in compliance with regulatory & company standards.

This position reports to the Team Lead – Innovation and Custom Design and is part of the Engineering team located in Bangalore and will be an on-site role.

In this role, you will have the opportunity to:

• Coordinate and perform the Equipment qualification and related activities for any newly introduced equipment to the facility or revalidations triggering due to any changes.
• Supporting activities like calibration, preventive maintenance, and any activity supporting through equipment / instrument life cycle.
• Co-ordination with suppliers for any ‘Special purpose equipment’ to be procured that supports organizational growth.

The essential requirements of the job include:

• B.E in electrical / mechanical / manufacturing engineering with 5+ years of experience in Validation and Qualification activities in a manufacturing or industrial setting.
• Master’s degree in electrical / mechanical / manufacturing engineering with 3 – 5 years of experience in Validation and Qualification activities in a manufacturing or industrial setting.
• Any other degree with relevant technical knowledge will be considered.
• Risk assessment for Equipment and software validation.

It would be a plus if you also possess previous experience in:

• Understanding of global regulatory standards including FDA 21 CFR Part 820, ISO 13485, MDSAP.
• Experience in handling specialized custom equipment.
• Understanding of Software validation aspects.

Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

More Details : Danaher
More Jobs : TJN Careers