Senior Validation Engineer

1 month ago


Bengaluru, Karnataka, India TE Connectivity Full time
Job Overview

The Global Senior Computer Systems Validation Engineer will play a crucial role in ensuring the validation of TE Enterprise systems deployed within TE Medical. This position requires expertise in validating computer systems, including bespoke enhancements and bolt-on applications, to meet global validation standards.

Key Responsibilities
  • Develop and deliver software validation requirements for TE Enterprise system implementations, including label printing systems integrated with ERP (SAP).
  • Provide guidance to internal and external teams on computer system validation requirements to ensure compliance with cGMP standards.
  • Maintain a strong working knowledge of regional and international quality system regulations, such as 21 CFR Part 820, 21 CFR Part 11, Annex 11, and ISO 13485:2016.
  • Execute global validation strategies, including protocols and reports, to ensure adherence to company procedures and regulatory standards.
  • Coordinate software validation and data migration activities across global teams.
  • Ensure test scripts are completed in alignment with the company's Good Documentation Practices (GDP) SOP and the project's Validation Plan requirements.
  • Support test deviation resolution and apply systematic problem-solving approaches to identify and prioritize issues.
  • Collaborate proactively with project leaders, IT teams, and local implementation teams to ensure project milestones are met.
  • Participate in global compliance projects as defined by the Global Quality Systems team.
  • Provide validation expertise in risk assessment processes and lead best practices for software compliance throughout the organization.
  • Cultivate and maintain a culture of quality and compliance within the organization.
Qualifications and Experience
  • Bachelor's or Master's degree in Science, Engineering, or Software discipline.
  • Minimum 5 years of relevant experience, with at least 3 years in software quality/compliance or software assurance roles.
  • In-depth knowledge of regional and international quality system requirements (21 CFR 820, ISO 13485, CFR Part 11, and cGxP).
  • Familiarity with IEC 62304, IEC 82304, GDPR, and ISO 14971 is advantageous.
  • Strong understanding of how various quality system elements connect and interact.
  • Experience with "Agile" software development methodologies and the ability to engage technically with development teams and testers.
  • Excellent verbal and written communication skills with experience presenting to leadership.
  • Fluency in English is required.
  • Creative and innovative problem-solving abilities.
  • Proven experience managing projects and driving deliverables to completion.
  • Experience in S/4 HANA is a plus.
  • Ability to work independently and within a team.


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