JoseCotto

7/28/2015
Canovanas, PR

Position Desired

Process Engineering
Anywhere in DC; Anywhere in FL; Anywhere in GA; Anywhere in NC; Anywhere in NY
Yes

Resume

OBJECTIVE

To obtain a position in a highly competitive and challenging company in which I can apply my knowledge and experience in the management and engineering areas in the benefits of the company.

WORK HISTORY

April 2013 – Present Eli Lilly; Lilly del Caribe Inc.
Manufacturing Production Manager (Biotechnology)

Eli Lilly; Lilly del Caribe Inc.
Emergency Brigade (Hazmat) Incident Commander

Eli Lilly; Lilly del Caribe Inc.
Project Start-Up Leader

April 2012 – April 2013 Eli Lilly; Lilly del Caribe Inc.
Commissioning and Qualification Team Leader (Supervisor) and Responsible Engineer (Process Engineering)

October 2007 – April 2012 Eli Lilly; Lilly del Caribe Inc.
Process Engineer

August 2003 – September 2007 Merck Sharp and Dohme Inc.
Manufacturing Engineer, Pharmaceutical Operations

WORK EXPERIENCE
Management
o Lead a group of 60+ in the Manufacturing Operations. Provide management oversight for the operational resources of assigned Process Team(s) including shift supervisors.
o Provide leadership to multidisciplinary team (Process Engineer, Scientist, Manufacturing operators, Reliability/Maintenance and Automation Engineer) in the Company production and Tech Agenda.
o Provide guidance and consulting to the operations shift supervisors
o Participate on the Process Assistant/Supervisors development project.
o Facilitate team goals and lead multidisciplinary teams in order to comply with business objectives (for example, six sigma initiatives, Process Team objectives, special investigation efforts, etc.)
o Establish metrics for the team and continuously (monthly, quarterly or annually) monitor the team progress.
o Conduct Employee Relations investigations, manage any disciplinary actions following the established procedure for all the people under his/her organization.
o Guide process team to be compliance driven of product quality FDA, European, and oriental agencies as well of safety and environmental agencies OSHA and EPA.
o Apply Six Sigma tools in order to improve company processes for example processes downtime and cycle time.


Project Start-Up Leader
o Lead multidisciplinary team for the delivery of the expansion manufacturing operations project (Construction rep, C&Q Champion, Process Engineer, Scientist, Scheduler, Reliability/Maintenance and Automation Engineer).
o Guide the team in the Project delivery phases; construction, equipment qualification, process validation and start up.
o Develop a strategy for delivery of the project during manufacturing operations at same time.
o Plan development for manufacturing operations shutdown.

Commissioning and Qualification (C&Q) Team Leader
o Lead C&Q plan within the production plan including equipment documentation as installation and operational (IC/OC/IQ/OQ and Temperature studies) testing.
o Provide guidance to the engineers in the testing design.
o Participate on the C&Q Strategy Plan for a Building expansion project. Implement with the C&Q group and optimization in the C&Q strategy by minimizing the execution and document approval times.
o
Process and Manufacturing Engineering
o Industrial equipment troubleshooting. Exposure to Control systems Delta V (Controllers) and PLCs.
o Biotechnology unit operations knowledge; Ion exchange chromatography technique, HPLC, Tangential Flow filtration and biological reactions.
o Pharmaceutical unit operations knowledge; capsules, packaging, fluid bed drying, mixing and micronization.
o Design and execute equipment qualification testing (IC/OC/IQ/OQ)
o Knowledge on RCRA, Leak and Detection program, Process Safety programs. Lead Process Safety Hazard reviews.
o Process Monitoring using tools as OSI PI, Delta V historian.
o Perform Investigation using methodology as Root Cause analysis, Kepner Tregoe.
o Processes cycle ...

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