SIGMAnet (October 2011 – Present)
Sales Engineer/Systems Engineer
Install and configure Dell EqualLogic shared storage and additional Cisco UCS servers running ESX 4.1 to allow for HA, DRS, VMmotion, etc. Migrate existing local storage to Dell EqualLogic arrays and validate functionality for New York US, London UK, Bremen DE sites increasing redundancy and reliability of production systems.
PACIV-USA (2004-2011)
Senior Automation/Validation Engineer
Eli Lilly Indianapolis, USA
Lead a team of highly professional Controls and Instrumentation engineers. Coordinating activities of the team and liaising with customers to ensure satisfaction.
Responsible for design, installation, program and startup of a new medical device assembly line leveraging multi-axis controllers.
Pfizer Pharmaceuticals (Biotech), Havant, UK
Drove implementation of backup and disaster recovery procedures for all packaging lines containing components manufactured by 10 distinct international firms.
Led and developed technical training on new and current packaging equipment in order to a maintain operations in compliance with GMP practices.
Audited and evaluated the compliance status of the existing BMS system in order to ensure continuous operation and conjunction with FDA and MHRA regulatory agency requirements.
GlaxoSmithKline, Global Manufacturing and Supply, Crawley, UK
Led a team of highly professional software developers in identifying and correcting hardware and software discrepancies, hardware installation, software configuration and application programming for a new packaging line. Coordinated/communicated between English and Italian teams to ensure customer satisfaction and regulatory agency requirements.
Managed control, automation and data accusations system for packaging lines projects from feasibility/ specification through to commissioning and handover.
Provided support to the validation and quality department during the qualification lifecycle activities for new equipment as well as ensuring FDA and MHRA regulatory agency requirements.
Eli Lilly Basingstoke, UK
Developed and coordinated retirement activities and deliverables for computer systems for pharmaceutical manufacturing site.
Control system and validation support for packaging and manufacturing equipment by 12 distinct international firms.
Drove implementation of backup and disaster recovery procedures for all packaging lines containing components manufactured by 7 distinct international firms.
Execution of the retirement plans on automation equipment which included backups, account management and archiving of audit trails.
Eli Lilly Indianapolis, USA
Responsible for PLC code change as well as the update of associated CSV documentation for PLC controlled packaging line for the products Cialis and Byette.
Responsible for remediation of CSV documentation for utilities PLCs including user requirements, design, traceability matrix, testing and test summary report.
Roche Diagnostics Indianapolis, USA
Team leader of 12 persons responsible for CSV life cycle of Comfort Curve and Aviva Accu-Chek product lines including commissioning and implementation of PLC code.
Responsible for the validation of automated medical device production and packaging line, and of vial integration-leak detection system for customer inquiry which included qualification of the laboratory equipment.
Eli Lilly Caribe Carolina Puerto Rico.
Champion lead responsible to coordinate the writer team efforts to meet execution schedules for DeltaV process cell application software release phase testing for Purification, Fermentation and Utilities at a new biotechnology. ᠕...
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