Industrial IT Engineer

Duties and Responsibilities

· 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.

· Assist the translation of compliance requirements into test conditions and expected results for application functionality, and acceptance testing (IQ, OQ, PQ, FAT, SAT)

· Drive development and execution of change management and training throughout the organization during the implementation and ongoing use of system applications.

· Understand and ensure the use of existing standards for design and governance.

· Architect system specific topology and adapt/integrate it into existing infrastructure.

· 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.

Skills/Knowledge Required

· 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.

· Experience in Computer System Validation.

· Awareness of 21-CFR Part 11, Eudralex, MHRA.

· Fully operational in French and English.