Senior Validation Engineer
1 month ago
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.
- 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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