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.
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.
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.
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.
Web-based requirements, architecture, Agile / SCRUM methodology.
Real Time Data Management and Interfaces (e.g. : Kepware, OSI PI) a strong plus
Serialization technologies (Laetus) a strong plus
Six Sigma, Lean or Business Process Change Techniques a plus
Languages : French + English