AIT Engineer - Laboratory Systems
- Work with QC lab Business Analyst in planning for addition of Analytical Instrumentation into newly constructed Laboratory
- Assist in sandboxing of vendor software to drive requirement specifications and configuration specifications
- Assist in testing of data integrity requirements
- Work with site IT on imaging lab instrument PC's with Clients Win 10 lab image.
- Track IT hardware inventory for QC Lab project
- Work with site QC on generation of requirement specification and tracing of requirements into UAT
- Participate in execution of IOQ protocols for lab analytical instruments
- Generate any automation change control documentation required for introducing new systems to the site
- Work with site AIT department on generation of SOP's(Business Continuity plans, backup strategy…etc)
- BS in Engineering, Computer Science, or other technical degree. 2 or more years of experience in project/automation/IT support and/or Vaccines / Pharmaceutical Manufacturing front line supervision.
- Excellent understanding of cGMP's, SDLC methodologies and LEAN/MPS/ Sigma principles.
- Excellent facilitation, problem solving, and decision-making skills.
- Demonstrated ability to analyse and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.
- Proven facilitation, meeting/workshop management and change management skills are essential, along with excellent written and oral communication skills, as well as strong presentation skills.
- Strong understanding of qualification of lab Analytical systems
- Understanding of Data Integrity requirements for Lab and Automation systems