Project Management
Problem Statement
To build the fastest syringe production line in USA and produce 50 million syringes per year.
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Approach
Due to the skills I gained at Xyntek and successful completion of my projects at Sanofi last year, I was hired through Xyntek as an SME to help build and manage the fastest syringe inspection and packaging line. As part of this project, my tasks are:
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Pro-actively track & manage project KPIs, milestones and deliverables.
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Enabling cross-functional communication across various departments at Sanofi: Engineering, Manufacturing, Production, Quality, Procurement, Safety to achieve key project milestones and deliverables
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Support/perform design reviews, FMEA’s, risk / hazard analysis & establishing technical requirements.
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Working with the general contractor to construct a new packaging room facility from the ground up.
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Manage external OEM vendors to stringent timelines and capability requirements through URS, RFQ, design reviews, process characterization and equipment acceptance (FAT & SAT).
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Working with suppliers to provide all necessary consumables strictly according to technical specifications.
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Establish serialization objectives and guide through the site requirements for serialization of new drugs.
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Prepare technical documentation such as URS, FDS, technical specifications, change control, etc
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Due to confidentiality reasons since the project is still ongoing, I cannot disclose further information.
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Project KPIs:
1.Cost: CapEx = $20M
2.Line Speed = 600 syringes per minute
3.Volume = 50M syringes
4.Line Yield = 98%
5.Changeover time = 3hrs
6.Ramp up time = 90 days
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