For our client, a global pharmaceutical company we are looking for an IT Manufacturing C&Q engineer.
Our client is a global biopharmaceutical company located near Neuchatel, Switzerland
Focused on R&D and delivery of innovative medicines across several therapeutic areas, including oncology, haematology, immunology, and CVD.
Main duties and responsibilities for this role are:
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, OQ, PQ, FAT, SAT)
Factory acceptance testing (FAT) would be in EU countries
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 standards to capitalize on lessons learned.
Define new versatile solutions covering abstract User Requirements to fulfil unmet needs.
Implement specific standalone and interconnected computerized system supporting activities like Production (Blending, Encapsulation, Tablet Press, Blistering, Bottling, Room Monitoring System and other various equipment used for the manufacturing.
Usage of a wide variety of Information Technology skills to configure systems, and implement backup mechanisms for flat files, databases, etc. Deploy proper privileges on the 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 the 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 systems may be required. Usage of Kepware technology and Open Platform Communications protocol will be required.
Our client is looking for someone who has:
Pharmaceutical, Biotechnology or Life Science industry experience.
3-5 years’ experience as an IT Engineer running projects from requirements to delivery of final product and documentation included.
Familiar with Change Management tools and regulated document authoring.
Commercial Off-The-Shelf (COTS) and Web-based requirements, architecture, Agile/SCRUM methodology.
Real-Time Data Management and Interfaces (e.g.: Kepware, OSI PI), a strong plus
Six Sigma, Lean or Business Process Change Techniques a plus
Technical diploma in Information Systems or equivalent experience
Experience in Computer System Validation.
Awareness of 21-CFR Part 11, Eudralex, MHRA
Awareness of business and enterprise architecture
Fully operational in French and English
Autonomous in analysis, problem-solving and achieving deliverables
Oral and Written communication
Constructive influencing of colleagues to a positive outcome
Only applicants eligible to work in Switzerland will be considered e.g. Swiss nationals, current Swiss work permit holders or cross-border EU citizens.
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