Merck Life Science
GxP Systems Engineer
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Work Your Magic with us!
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.
Your Role
Join our dynamic team to ensure our GxP computer systems and lab software remain compliant across their entire lifecycle. In this hands-on position, you’ll handle system administration, manage user access, maintain critical quality records, and perform essential software troubleshooting. You'll act as the key liaison between laboratory users, IT, Validation, and external vendors to drive seamless system implementations and upgrades. Working across global departments, your expertise directly protects data integrity and streamlines site operations.
Key Responsibilities
- Perform administration tasks for a variety of GxP systems and associated software in a regulated (GxP) environment following defined procedures.
- Defining, assigning, installing, configuring, documenting, and managing user access across CTS.
- Own, manage, and maintain Quality records for GxP system lifecycle activities (including but not limited to user access and audit trail reviews, change management, SOP management, Events/CAPAs, Disaster Recovery and Business Continuity processes, Data Integrity assessments, and implementing Data Integrity controls).
- 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.
- Act as liaison with wider business and collaborate between CTS departments on lab system 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.
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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.
- Proven hands-on experience in GxP system administration, user access management, and troubleshooting.
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Preferred Qualifications
- 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 believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity!
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