Industrial IT Engineer (CSV)

Join the team and be part of an innovative company that values inclusion, growth, and impact. Our dynamic work environment offers brilliant opportunities for advancement. We're seeking talented and driven individuals who share our passion for making a difference within the Life Science industry.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Widespread IT technical knowledge such as Operating System, Infrastructure and Networking. Programming is excluded and development of script is very limited. Proficiency into Computer System Validation in the pharmaceutical environment is required.
• The accountability of the worker is the improvement or full implementation of off-the-shelf and configurable (Gamp 3 and 4) standalone and interconnected standalones, regulated by the GmPs. To a lesser extent, he/she will collaborate on (Gamp 5) worldwide/interconnected systems.
• 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)
• 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.: Blending, Encapsulation, Tablet Press, 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.

Key Skills and Requirements:

• Pharmaceutical, Biotechnology, Life Science industry experience is a must.
• 8-10 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.
• Real Time Data Management and Interfaces (e.g.: Kepware…) a strong plus.
• Proven experience in the installation and qualification of Aveva-PI suites is a strong plus.
• Proven experience in the installation and qualification of Building automation systems (Desigo, RMS Rotronic) is 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.
• Business acumen.
• Autonomous in analysis, problem solving and achieving deliverables.
• Oral and Written communication.
• Constructive influencing

If you are having difficulty in applying or if you have any questions, please contact Saulge Hubert at:

s.hubert@proclinical.com

CH: +41 61 508 7073

WhatsApp: +41 61 508 7073

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.