IT Engineer - GmP infrastructure
IT Engineer
Experis IT is Europe's leading IT recruitment agency. With offices in Zurich, Basel, Geneva and Lausanne, we specialise in the Information Technology sector.
Mission / Rôle :
* Information Technology Requirements, GmP Regulation, must be explained
and obtained from the vendor of system. When necessary, the Engineer, may
have to customize the system, or adapt the process, to comply the GmPs.
* Guarantee Data Integrity of the system into its environment and process.
* Design 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.
* Adjust the number of deliverables, their quality and complexity to guarantee the
respect of timelines and fit to validation approach.
* Facilitate meetings with business colleagues on IT topics
* Assist the translation of compliance requirements into test conditions and
expected results for application functionality, and acceptance testing (IQ,PQ,FAT)
* Understand business objectives, processes, and strategies.
* Drive development and execution of change management and training throughout
the organization during the implementation and ongoing use of system
applications
* Ability to work strategically and independently with internal and external groups on
multiple simultaneous projects
Understand and ensure the use of existing standards for design and governance.
* Architect system specific topology and adapt/integrate it into existing
infrastructure.
* Collaborate with IT groups to ensure standards are applied for technological tools.
* Use existing standard to capitalize on lessons learned.
* Define new versatile solutions covering abstract User Requirements to fulfill unmet
needs.
* Implement specific standalone and interconnected computerized system
supporting activities like Production (e.g.: Laetus Track & Trace, Blending,
Encapsulation, Tablet Press, Blistering, Bottling, Cartoning , Room Monitoring
System and other various equipment used for the manufacturing, packaging and
Quality Control of drug products.
* Usage of a wide variety of Information Technology skills to configure systems,
implement backup mechanism for flat files, databases, etc. Deploy proper
privileges on Operating System (Windows) and File Systems.
* Develop governance and "how to" Work Practices, including their Configuration
Specifications to allow the operational team to support and administer the newly
integrated system.
* Transmit information and follow up with specialists to obtain required configuration
of the global network, backup tool and infrastructure.
* Configure and setup local network, infrastructure, computers and applications.
* Preparation and configuration of interfaces between multiple system may be
required. Usage of Kepware technology and OPC protocol will be required
Experience / Qualifications:
* Pharmaceutical, Biotechnology, Life Science industry experience is a must.
* 3-5 years' experience as an IT Engineer running project from requirements to
delivery of final product and documentation included.
* Familiar with Change Management tools and regulated document authoring.
* COTS and Web-based requirements, architecture, Agile/SCRUM methodology.
Interested ? PLease do not hesitate to apply now ! You can as well visit my personal website to find out more opportunities : https://fr.experis.ch/antoine-wormser.
