GxP Systems Engineer

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. 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:

Previous experience in a 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.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