Digital Engineering Lab Systems Expert.

ulliManage 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. /liliProvide operational and project support by performing IT technical maintenance activities, performance analyses and troubleshooting of lab systems. /liliIn 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. /liliAdvise 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. /liliSupport Disaster Recovery activities, including periodic testing, to ensure the Business Continuity of lab systems. /liliProviding IT technical support and advice to the Quality Assurance (QA) department. /liliCommunicate about operational and project-related activities with internal contacts, both locally and within the international organization, and with external contacts. /li /ulh3Skills: /h3ulliKnowledge of bMicrosoft operating systems (Windows and Windows Server) /b. Relevant Microsoft certifications are an advantage. /lilibNetworking essentials, TCP/IP, antivirus solutions, remote administration, Active Directory /b and IT infrastructure in general. /liliBasic knowledge of bscripting (DOS command line, PowerShell) /b. /liliAble to work in a structured way and have good documentation skills. /liliFlexible and service-oriented. /liliGood communication and interpersonal skills. /liliBe able to communicate clearly and effectively, both verbally and in writing, in bDutch and English /b. /liliBe able to work independently and in a well-organized way. /liliExperience installing, troubleshooting, and maintaining Microsoft operating systems and applications. /liliKnowledge of bvalidation and qualification methodology /b is an advantage. /liliGood knowledge of bGMP, GAMP 5 and 21 CFR Part 11 /b is an advantage. /li /ulh3Job Description: /h3ulliManaging the servers, desktops and workstations within QC and TY. /liliDeveloping, documenting and maintaining installation procedures for client-server and other applications within QC and TY. /liliChecking and approving the GMP installation and configuration procedures for validation use. /liliInvestigate installation and configuration options of lab systems to determine an optimal implementation, based on the information provided by suppliers and third parties. /liliPlanning and executing maintenance activities for QC and TY applications and associated computer platforms. /liliPerforming archival requests, security and remediation activities. /liliPerformance evaluation and hardware and software troubleshooting of lab systems. /liliCollaborate 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. /liliLiaising with the corporate Digital organization and international colleagues from other Sanofi locations in the design of computer systems. /liliProviding 1st and 2nd line support. /liliEnsure compliance with both corporate and local Sanofi Digital and GMP procedures. /li /ul