AIT Laboratory Equipment Qualification Engineer
Role Description
The AIT Labs Engineer will be responsible for delivery of Automation and IT scope on one or more lab projects in the portfolio of capital projects managed by Global Engineering Solutions (GES).
This candidate will be required to work closely with the AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for qualification of laboratory systems.
Role Functions
(Functions include, but are not limited to, the following)
Partner with local project teams to deliver Automation and IT aspects of Laboratory capital projects.
Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with company standards. Liaise with site AIT group to add input to site SOPs for lab systems.
AuthorReviewApproval of qualification documents for lab systems – RS, CS, RTM etc.
Work with site teams on generation of requirement andor configuration specification and IOQ test protocols. Participate in execution of IOQ protocols for lab analytical instruments where required.
Provide input to the development of project schedules and document trackers.
Generate risk assessmentsvariance documentation and interface with site teams to close out same.
Work closely with the DDQ function to ensure compliance with company Quality standards.
Interface with BioNX site teams for Enterprise system deliverables such as Empower, LIMS, MODA, LabX and Acronis etc.
Drive efficiencies in execution of projects to reduce costs and cycle times based on standards
Ensures that SDLC is appropriately applied.
Knowledge, Skills, Education & Location Requirements
BSc in Engineering, Computer Science, and or other technical degree.
5 or more years of experience in project/automation/IT/CSV/IT and or a similar role with experience in laboratory analytical instrument qualification and system implementation.
Excellent facilitation, problem solving, collaboration and decision-making skills.
Ability to multitask and to handle tasks with competing priorities effectively and engage with stakeholders.
Demonstrated ability to troubleshoot, problem solve, analyse, and define business problems, develop business cases, and identify appropriate process and technological solutions are essential.
Proven facilitation, meeting/workshop management, project management and change management skills are essential.
Excellent written, oral communication skills, as well as strong presentation skills.
Experience with Laboratory systems such as Empower LIMS, MODA, LabX and Acronis.
Experience in automation equipment used in biopharma laboratories is an advantage.