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Software Validation Specialist, Kolkata

Created01/14/2022
Reference76204558294A4F5F925E53BF47A6BDD1
CategoryNot set
CountryIndia
CityKolkata
SalaryCompetitive
SCIEX

As a global leader in mass spectrometry, SCIEX delivers solutions for precision detection and quantification of molecules to help protect and advance the wellness and safety of all. Because of our 50 years of groundbreaking innovation, our customers can quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster, and keep food healthier and safer. At SCIEX, you'll find a rewarding role that amplifies your impact on the world and helps you realize life's potential.

SCIEX is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

About This Role

The Software Validation Specialist provides technical and business domain expertise to assist customers in validating mass spectrometry systems for 21 CFR Part 11 compliance in GxP regulated laboratory environments. The Software Validation Specialist is responsible for working with customers to modify and execute validation scripts addressing the customer's requirements, configurations, workflows, data management processes, etc.

Core Responsibilities
  • Delivers consultative software validation services to SCIEX customers
  • Works closely with customer IT, QA, and laboratory personnel throughout the entire validation process, (planning, documentation development, review, approval, and execution)
  • Manages validation project scope and timelines to both SCIEX and customer expectations
  • Coordinates engagements with local Field Service team
  • Provides customer training as needed for adapting customer workflows to validation strategy
  • Provides consulting services to customers based on the established Professional Services project management methodology
  • Helps customers identify, troubleshoot, and debug validation discrepancies and related software issues

Education and/or Work Experience Requirements:
  • Bachelor's degree (B.S./B.A.) in life sciences, informatics, information technology, computer science, or equivalent professional experience
  • Requires 2+ years of demonstrated experience in validating Life Sciences Systems in GLP and/or GMP laboratories
  • Demonstrated expertise in global regulatory frameworks and requirements as they apply to LC-MS systems and software

Critical Success Factors:
  • Teamwork - must be able to influence teams/associates from multiple disciplines/companies
  • Ability to influence others - must be able to inform, convince, and persuade others to action using DBS to drive sustainable results
  • Results orientation - must deliver sustainable results
  • Specific technical competencies - must possess skills necessary to be seen as credible
  • Communication-must be able to effectively communicate in both written and verbal forms

    When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

    Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.

If you've ever wondered what's within you, there's no better time to find out.

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you've ever wondered what's within you, there's no better time to find out.
EmployerDanaher Corporation