BMS Automation Engineer, with a strong background in design, implementation and commissioning of Building automation Management Solutions and Environmental Monitoring Systems in preferable Pharmaceutical regulated environments. Due to his / her experience s / he is able to review design and FAT / SAT documentation with an critical eye, in order to support the Technical system owner (TSO) in his responsibility to keep the system in his compliant state. .
In a nutshell after your review and working together with the project teams, the formal TSO and BSO trust on your judgements and quality, for formal sign-off by BSO and TSO.
- As final gatekeeper, review the created Design (Life cycle) FAT / SAT documentation / protocols that are created by the several BMS project teams, and make sure these have the correct technical aligned strategy and are defendable during a future inspection.
- Make sure you are aligned with, by working closely together with the Local TSO (Technical System Owner) and BSO (Business system Owner), with the task to evolve as a digital (remotely) TSO delegate by gaining trust by delivering quality in design, FAT / SAT documentation / protocols.
- Align with the so called “Equipment teams” on all your feedback, and make sure together with the Equipment lead and TSO to maintain a lean progress and update or create standardization that benefits the review cycles
- Pro-active mindset and coordinate when needed that supports and maintains the progress on the reviews.
Good To Have :
Having knowledge on MES Delta V integration, Siemens PLC,AVEVA OSIPIKnowledge of ISA95 / S88 standards & practical use of these standards in application design, Knowledge of Pharma manufacturing.Good Communication and Analytical skillsGood understanding of ITIL concepts.Agile Project Management.Knowledge of GxP, GAMP, 21 CFR Part 11