Hybrid Global Senior Computer Systems Validation Engineer Global Senior Computer Systems Validation Engineer with verification

The Global Computer Systems Validation Engineer will provide expert computer system validation support for the Global Enterprise Systems deployment in TE Medical.

Responsibilities

• Responsible for identifying and delivering software validation requirements for TE Enterprise system implementation including bespoke enhancements and bolt-on applications.
• Responsible for identifying and delivering software validation requirements for label printing systems interfacing with the ERP (SAP) system.
• Provides guidance and support to all internal and external departments to ensure understanding and compliance with the requirements of cGMP as applied to the validation program set down by company procedures and regulatory standards.
• Working knowledge of regional and international quality system requirements including 21CFRPart820, 21CFRPart11, Annex11, ISO13485:2016.
• Executes global validation strategies, protocols and reports ensuring compliance to all relevant procedures and standards. Track and report progress.
• Coordinates software validation and data migration activities
• Ensures Test Scripts are completed as per the company’s Good Documentation Practice (GDP) SOP and project’s Validation Plan requirements.
• Supports the test deviation process ensuring their successful resolution.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving issues.
• Proactively liaises with project leaders, IT professionals and local implementation project team to ensure project milestones are met.
• Takes part in Global Compliance projects defined by the Global Quality Systems team.
• Guides, coaches, and trains other employees on software compliance and drives best practices throughout the organization.
• Provides validation expertise for the risk assessment process.
• Reporting directly to the Global Quality Systems Manager.

What your background should look like:

Experience/Qualifications:

• Bachelor or master’s degree in science/Engineer/Software discipline.
• 5 years of related experience, including 3+ years' experience supporting software quality/compliance or software assurance.
• Working knowledge of regional and international quality system requirements including 21CFR 820, ISO 13485, CFR Part 11 and cGxP. Experience with IEC 62304, IEC 82304, GDPR and ISO 14971 is an advantage.
• Must have a good understanding of quality system requirements and how each quality system element connects.
• Experience in working with “Agile” software development methodologies and can engage at a technical level with software development teams and testers is desirable.
• Comfortable speaking and presenting to leadership.
• Strong written and verbal communication skills.
• Fluent in English
• Creative and innovative thinking skills
• Experience managing projects and project deliverables to completion.
• Experience in S/4 HANA would be an advantage
• Comfortable working independently and as part of a team.

Travel

• Willingness to travel domestically and internationally as needed (20% of time)
• Ability to work flex work hours as needed to support global sites across time-zones