Job Description

Work Your Magic with us! Ready to explore, break barriers, and discover more We know you\'ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people\'s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us Job Title:Validation Engineer Job Location: Peenya, Bangalore Role Description We are seeking a highly motivated and skilled Validation Engineer to join our APeC Field Service team. The Validation Engineer will be responsible for developing and implementing qualification - SAT, IQ and OQ - protocols hardware systems with added focus on CSV (Computer System Validation) protocols, Data integration protocols, and Domain connection protocols. The successful candidate should have a strong understanding of Validation and regulations including 21 CFR Part 11 and possess the necessary skills to ensure compliance. Developing service protocols ( SAT, IQ/OQ , PM , CSV, data & Domain integration ) for standard and custom range of hardware: equipment used in both Upstream & Downstream Bioprocessing. Demonstrate in-depth knowledge & understanding of 21 CFR Part 11 regulations and other relevant pharmaceutical guidelines. Stay up-to-date with regulatory guidelines & requirements, able to provide and achieve compliance in all validation activities. Collaborate with partners & cross-functional teams, including Quality Assurance, IT, and Field Service teams, to obtain necessary information in order to develop & create the validation protocol for service offerings. Participate actively in assigned Product Development Process (PDP) for projects based in India and or Molshiem, support to contribute to the success of the validation strategy and requirements. Engage and review with customers in discussions regarding User Requirements Specifications (URS). Responsible to conduct hardware operating tests and validations, ensuring functionality and compliance of the established protocols. Demonstrate excellent communication skills to effectively interact with customers, internal teams, and other stakeholders. Limited travel requirements. Bachelor\'s degree in Regulatory, Engineering or a related field. Minimum of 5 years of experience in qualification protocol development, CSV and Data Integrity validation within a regulated industry, preferably in the field service sector. Proven experience in CSV / data integration / domain connection protocol development and execution. Strong knowledge of 21 CFR Part 11 regulations and other relevant regulatory requirements. Experience participating in the Product Development Process (PDP) is preferred. Ability to review and discuss User Requirements Specifications (URS) with customers as needed. Proficiency in hardware operating procedures and validations. Excellent communication skills, both verbal and written to effectively collaborate with stakeholders. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

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