Senior Enterprise Application Engineer – PDx Quality

4 days ago

INDBengaluruEPIP Phase II, India GE HealthCare Full time ₹ 12,00,000 - ₹ 24,00,000 per year
Job Description SummaryAre you ready to make a significant impact in the world of Pharmaceutical Diagnostics (PDx)? Join our dynamic PDx IT team as a Senior Enterprise Applications Engineer

In this pivotal role, you will collaborate closely with our Quality colleagues to shape technical roadmaps and
implement technology solutions in a cost-effective way which aligns with strategic roadmap that helps achieve business objectives.Job Description

Essential Responsibilities:

  • Implement, and maintain IT systems and software for the Quality department to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH).

  • Manage the investigation and resolution of IT-related issues, including system non-conformances and deviations.

  • Translate unstructured or ambiguous requests into actionable technical requirements through problem decomposition and planning.

  • Prioritize continuously in accordance with the understanding and validation of customer problems and needs.

  • Stay updated with industry trends and regulatory changes to ensure compliance and best practices.

  • Lead the implementation of new IT technologies and methodologies to enhance efficiency and accuracy.

  • Own the short-term product roadmap and its integration into a larger application or strategic roadmap.

  • Strong written and verbal communication skills.

Basic Qualifications:

  • A Bachelor's Degree in Computer Science or "STEM" Majors (Science, Technology, Engineering and Math).

  • A minimum of 6 years of relevant professional experience working in the Pharma or IT Industry including experience with Salesforce development activities.

  • Proven experience in Salesforce development (Apex, Visualforce, Lightning Components, Flows).

  • Hands-on experience with Salesforce architecture and integration patterns.

  • Experience with Salesforce-based QMS platforms such as Trackwise Digital or Salesforce Health Cloud.

  • Familiarity with Salesforce DevOps tools and CI/CD pipelines.

  • Expert understanding of analysis & design and system architecture concepts.

  • Expert knowledge of CSV lifecycle with understanding of GxP (GLP/GCP/GMP), 21CFR Part 11, EU Annex 11. Familiarity with audit trails, electronic signatures, and validation documentation.

  • Ability to execute in a technical environment and willingness to engage and understand technical solutions, challenges and issues.

Desired Characteristics:

  • Experience implementing Trackwise Digital on Salesforce platform.

  • Understanding of QMS processes such as CAPA, Deviations, Change Control, and Audits.

  • Ability to configure and customize Trackwise workflows and reports.

  • Experience with Cloud technologies, Java, SQL, Integrations, API

  • Experience working in remote / global teams.

  • Ability to make technology choices based on experience and willingness to take calculated risks and experiment with newer technologies.

  • Ability to develop partnership with stakeholders and develop an inclusive & collaborative environment.

Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

Relocation Assistance Provided: No

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