Industrial it engineer

Ph3The Company /h3 pOur client is a global biopharmaceutical company located near Neuchatel, Switzerland. Focused on RD and delivery of innovative medicines across several therapeutic areas, including oncology, haematology, immunology, and CVD. /p h3The Role /h3 pThe IT engineer will be involved in improving or fully implementing off-the-shelf and configurable (Gamp 3 and 4) standalone and interconnected standalone, regulated by GmP. To a lesser extent, he/she will collaborate on (Gamp 5) worldwide/interconnected systems. He/she will have widespread IT technical knowledge such as operating systems, infrastructure and networking and proficiency in computer system validation in the pharmaceutical industry. Programming is excluded and development of script is very limited. /p h3Duties And Responsibilities /h3 ul liInformation Technology Requirements, GmP Regulation, must be explained and obtained from the vendor of the system. When necessary, the Engineer may have to customize the system, or adapt the process, to comply with the GmPs. /li liGuarantee Data Integrity of the system in its environment and process. /li liDesign through elicits, analyzes, documents, and validates detailed user / functional / non-functional requirements; identify gaps between system capabilities and requirements to ensure that business needs are met. /li liAdjust the number of deliverables, their quality and complexity to guarantee the respect of timelines and fit the validation approach. /li liFacilitate meetings with business colleagues on IT topics. /li liAssist the translation of compliance requirements into test conditions and expected results for application functionality, and acceptance testing (IQ, OQ, PQ, FAT, SAT). /li liUnderstand business objectives, processes, and strategies. /li liDrive development and execution of change management and training throughout the organization during the implementation and ongoing use of system applications. /li liAbility to work strategically and independently with internal and external groups on multiple simultaneous projects. /li liUnderstand and ensure the use of existing standards for design and governance. /li liArchitect system-specific topology and adapt/integrate it into existing infrastructure. /li liCollaborate with IT groups to ensure standards are applied for technological tools. /li liUse existing standards to capitalize on lessons learned. /li liDefine new versatile solutions covering abstract User Requirements to fulfil unmet needs. /li liImplement specific standalone and interconnected computerized systems supporting activities like Production (e.g.: Blending, Encapsulation, Tablet Press, Room Monitoring System) and other various equipment used for the manufacturing, packaging, and Quality Control of drug products. /li liUsage of a wide variety of Information Technology skills to configure systems, implement backup mechanism for flat files, databases, etc. Deploy proper privileges on the Operating System (Windows) and File Systems. /li liDevelop governance and “how to” Work Practices, including their Configuration Specifications to allow the operational team to support and administer the newly integrated system. /li liTransmit information and follow up with specialists to obtain the required configuration of the global network, backup tool and infrastructure. /li liConfigure and set up local network, infrastructure, computers and applications. /li liPreparation and configuration of interfaces between multiple systems may be required. Usage of Kepware technology and OPC protocol will be required. /li /ul h3You /h3 ul liPharmaceutical, Biotechnology, Life Science industry experience is a must. /li li8-10 years' experience as an IT Engineer running projects from requirements to delivery of final product and documentation included. /li liFamiliar with Change Management tools and regulated document authoring. /li liCOTS and Web-based requirements, architecture, Agile/SCRUM methodology. /li liReal-Time Data Management and Interfaces (e.g.: Kepware…) a strong plus. /li liProven experience in the installation and qualification of Aveva-PI suites is a strong plus. /li liProven experience in the installation and qualification of Building automation systems (Desigo, RMS Rotronic) is a strong plus. /li liSix Sigma, Lean or Business Process Change Techniques a plus. /li liTechnical diploma in Information Systems or equivalent experience. /li liExperience in Computer System Validation. /li liAwareness of 21-CFR Part 11, Eudralex, MHRA. /li liAwareness of business and enterprise architecture. /li liFully operational in French and English. /li liBusiness acumen. /li liAutonomous in analysis, problem-solving and achieving deliverables. /li liOral and Written communication. /li liConstructive influencing of colleagues to positive outcomes. /li /ul pAll applicants must be authorized to work in Switzerland and be of Swiss nationality or have a valid Swiss working permit. /p /p #J-18808-Ljbffr