George Cornell Email & Phone Number

Fishers, In, Us

Fishers, In, Us

Indianapolis, Indiana Area

Manages the delivery of automated device assembly equipment in support of new product launches, capacity expansion and ongoing support for global Lilly and non-Lilly locations. Responsible to lead engineering technical project support to define requirements, identify equipment suppliers, and deliver equipment to manufacturing sites (Lilly or outsourced). -Vendor Capability Assessment/Process Development: Evaluate and recommend technology for utilization in Lilly device packaging and assembly lines; develop and communicate business case. -Technical Leadership: Learn, understand and follow laws, regulations, and guidelines applicable to pharmaceutical packaging. Define and mitigate risks, including use Failure Modes and Effects Analysis (FMEA). Create and execute project work plans and revise as appropriate to meet changing needs and requirements. Develop protocols for engineering studies and write technical reports. Provide necessary technical support for manufacturing and packaging operations and troubleshoot escalated issues.

-Provide technical expertise with delivery of automated device assembly and packaging equipment in support of new product launches, capacity expansion and ongoing support for global Lilly and non-Lilly locations. -Vendor Assessment: Assess technology -Technical Leadership: Learn, understand and follow laws, regulations, and guidelines applicable to pharmaceutical packaging.

Customer-driven sales professional with excellent communication and interpersonal skills dealing with, co-workers and management in a global marketplace. Supported packaging processes and supplying customers in the industry with high quality system solutions and equipment. Technology Transfer to support customer’s project needs to ensure successful product launches.Leveraged operations and engineering knowledge to meet customers manufacturing quality, supply and price requirements within the prescribed budgets and timeframes.Managed customers project timelines to ensure seamless on-time tooling and equipment solution deliveries.

Reviewed the basis for the qualification of the equipment and ensure that the equipment/system is appropriate for the intended purpose. Ensured significant changes, maintenance and other interventions did not adversely impact the qualification state of the equipment. Including review and/or approval of level 2 & 3 equipment and/or automation changes. Conducted and/or oversaw the periodic review of equipment systems to verify that they remain in a state fit for their intended use. Work with MS&T rep to review and maintain the accuracy of the PFD/SFD and pFMEA to define and mitigate risks. Approved technical release statements on commissioning and qualification packages for new systems in accordance with the requirements of GQS 201 and/or local procedures. Provided guidance on key elements of return to service requirements for equipment after interventions, such as maintenance. Provided technical oversight for less experienced engineers. Provided technical guidance and approval of Device Studies & Reports (DSR) and Periodic Reviews (PR). Reviewed the development or major revisions of Equipment Specific Instructions (ESI). Reviewed and/or approved significant changes, maintenance and other interventions for potential adverse impact on the safety integrity of the equipment or process

Participated on a team of three associates; overseeing counterfeit investigation efforts. Ensured products and components met prescribed specifications. Served as an analytical resource to maintain cGMP compliance both at US and OUS sites. Reviewed and approved documentation for process controls, investigations, qualification, validation, specifications, operating procedures, and change controls. Developed anti-counterfeit strain analysis data base used to investigate acquired samples; participated in FBI raids of suspect distributors, consulted with Immigration Customs and Enforcement, FDA Forensic Chemistry Lab and OCI as requested.Established and implemented a solution to aid wholesalers on product identification that addressed concerns that attributed to increasing incidents of discrepancies between items shipped and those received. Once implemented, wholesaler discrepancy charge backs were reduced by $1.4 MM.Created and implemented processes to foster collaboration between US employees and OUS counterparts to meet project implementation needs, including after action updates to facilitate future project efforts.

Responsible for the Lab Systems packaging operations, including maintenance of the equipment and coordination of all packaging components. Led quality assurance efforts for product labeling and packaging operations. Ensured products and components met customer specifications. Established cost savings and service improvement goals.Developed and established the packaging standards for incoming shipments for Roche Diagnostics Corporation which reduced incoming damage claims by 30%. Created and implemented packaging design solutions for the shipment of hazardous materials which generated a $1.2MM cost savings.

Design, develop and improve packaging for OEM automotive and consumer sound systems.

Design and implement packaging solutions for OEM and Aftermarket packaging of vehicle windshield wipers and wiper systems.