Digital Engineering Lab Systems Expert.

Digital Engineering Lab Systems Expert Customer: Sanofi

Location:
Geel Start Date: ASAP Duration: Until 31/12/2026 (renewable) Submission Deadline: ASAP Activities:
• Manage and support the IT infrastructure and lab software of GMP and non-GMP lab systems within the Quality Control (QC) and Manufacturing Science and Technology (MSAT/Technology – TY) departments.
• Provide operational and project support by performing IT technical maintenance activities, performance analyses and troubleshooting of lab systems.
• In the context of validation and implementation of lab systems, define configurations and provide support for application installations and IT infrastructure components. Provide advice on the application lifecycle and prepare and execute upgrades. Preparation of requirements, architecture and design specifications and installation instructions for lab software.
• Advise the Validation Department on the security of raw data generated by GMP systems, and integrate the requirements around Data Integrity integrity into the architecture and design specifications of GMP lab systems.
• Support Disaster Recovery activities, including periodic testing, to ensure the Business Continuity of lab systems.
• Providing IT technical support and advice to the Quality Assurance (QA) department.
• Communicate about operational and project-related activities with internal contacts, both locally and within the international organization, and with external contacts.

Skills:
• Knowledge of Microsoft operating systems (Windows and Windows Server). Relevant Microsoft certifications are an advantage.
• Networking essentials, TCP/IP, antivirus solutions, remote administration, Active Directory and IT infrastructure in general.
• Basic knowledge of scripting (DOS command line, PowerShell).
• Able to work in a structured way and have good documentation skills.
• Flexible and service-oriented.
• Good communication and interpersonal skills.
• Be able to communicate clearly and effectively, both verbally and in writing, in Dutch and English.
• Be able to work independently and in a well-organized way.
• Experience installing, troubleshooting, and maintaining Microsoft operating systems and applications.
• Knowledge of validation and qualification methodology is an advantage.
• Good knowledge of GMP, GAMP 5 and 21 CFR Part 11 is an advantage.

Job Description
• Managing the servers, desktops and workstations within QC and TY.
• Developing, documenting and maintaining installation procedures for client-server and other applications within QC and TY.
• Checking and approving the GMP installation and configuration procedures for validation use.
• Investigate installation and configuration options of lab systems to determine an optimal implementation, based on the information provided by suppliers and third parties.
• Planning and executing maintenance activities for QC and TY applications and associated computer platforms.
• Performing archival requests, security and remediation activities.
• Performance evaluation and hardware and software troubleshooting of lab systems.
• Collaborate with QC, TY, and Validation departments in management, maintenance, and validation activities for lab applications, with an important role in developing and documenting architecture and design specifications.
• Liaising with the corporate Digital organization and international colleagues from other Sanofi locations in the design of computer systems.
• Providing 1st and 2nd line support.
• Ensure compliance with both corporate and local Sanofi Digital and GMP procedures.