Overview
Skills
Job Details
Job Skills:
Strong background in QC Lab systems and Benchtop Lab systems/equipment (covering all L2/3/4 levels)
Understanding of Lab systems integrations with SAP, MES, Labelling and other enterprise systems.
Experience working in an highly matrixes organization and stakeholder management (including senior executives)
Pharma and GxP experience must have.
Project Management experience preferred. Multiple project management methodologies preferred (waterfall, agile, kanban )
Good understanding of labs business processes and qualification process.
Good understanding of IT network and infrastructure.
Experience with new green field implementation of new manufacturing site.
Understanding of ALM/TLM and TIME models.
Key responsibility areas:
Greenfield mfg site - Labs Project Tech Coordination: Scope of Lab Systems( Labware, Softmaxpro, Nugenesis, Empower, Smart QA/QC and Tanium Enforce). Single point of IT contact to business team. Develop integrated IT scope, integrated plan, integrated estimates/funding, and identify risks early. Manage IT RAID. Ensure all the dependents teams are communicating and Act as Project Manager where required and act as Project Manager where required.
IT Assessment and strategy proposal for of bench top lab equipment:- We will launch an assessment of each benchtop lab application to better understand their roadmaps, users, funding source, resources supporting, tech debt, have these applications have any IT support in the past (or were they perhaps business administered without proper IT engagement). Scope is new manufacturing sites and existing sites. We should also be curious as to are they even needed. From this assessment we will determine which of the applications are capabilities we should own in quality and what resources will be needed to support these applications. We should have this assessment completed in time for LRFP and it would also involve HR timelines.