GxP Systems Engineer
Millipore Corporation

Job Info

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Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

The individual performs a variety of tasks within the Transformation Office and Quality department that are associated with maintaining regulatory compliance of GxP computer systems (and other business managed applications) throughout their lifecycle. Will participate in and/or lead project teams across global operational departments to implement business-managed applications.

Essential Job Functions:

• Perform administration tasks for a variety of GxP systems and associated software in a regulated (GxP) environment following defined procedures. Defining, assigning, documenting and managing user access across CTS
• Develop and implement processes to ensure Data Integrity assurance: focusing on accuracy, reliability, and security across organizational systems
• Lead Software/System Development Lifecycle (SDLC) activities and manage Operational Technology (OT) deliverables (including but not limited to System Inventory management, Risk Assessment, Infrastructure Management, Data Classification and Protection, Data Privacy assessments and Service Level Agreements)
• Own, manage and maintain GxP system lifecycle activities (including but not limited to Change management, SOP management, Events/CAPAs, Disaster Recovery and Business Continuity processes, Data Integrity assessments and implementing Data Integrity controls)
• Act as liaison with wider business and collaborate between CTS departments on all SDLC activities (including but not limited to Validation, Change Management, Periodic Review, Decommissioning) for GxP computerized systems. Ensures transition of OT Systems from project to operations
• Responsible for troubleshooting, incident management, servicing, maintenance, or other support functions for software or firmware associated with laboratory systems including OS upgrades, patch management, Infrastructure management and system security
• Acts as liaison and interface between laboratory users, IT, OT, Engineering, Validation and external vendors in selection, implementation and lifecycle management of laboratory systems Responsible for maintenance plan and contracts with vendors
• Responsible for timely communication of status of user requests and/or system outage reporting (e.g., helpdesk tickets)

Who You Are

Minimum Qualifications:

• Bachelor of Science/IT (B.S.) or Bachelor of Arts (B.A.) degree in science or technical area
• 2 years' in a technical role supporting regulated software applications or laboratory systems

Preferred Qualifications:

• Minimum of 3 years' experience in regulated (GxP) environment
• Understanding of GxP regulations and guidelines including but not limited to GAMP 5, US Code of Federal Regs. 21 CFR Part 11 and Part 211, Eudralex Volume 4, Annex 11 & Annex 15, ICH Q7, Q8, Q9 & Q10
• Acts ethically and ensures quality of own work and that of others
• Works with agility and willing to embrace and implement change on a global scale
• Applies technology to drive digitalization, improve quality and increase customer value
• Excellent communication and facilitation skills (ability to lead cross-functional meetings, demonstrated ability to bring consensus among diverse cross-functional teams)
• Proficient knowledge and application of FDA and EU regulations (cGMP, GLP)
• Advanced knowledge and application of data integrity regulatory guidance (e.g., FDA, MHRA, WHO)
• Understand quality standards for GxP software applications and systems

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

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