Project Process
Resume:
# ** ****** * ****. ****** VEGA BAJA, P.R. *****
PHONE 787-***-**** • E-MAIL *****.**********@***.***
EDWIN O. RODRÍGUEZ ROSARIO
OBJECTIVE
Work in an industry to develop and improve my skills in the Chemical Engineering field and at the same time contributes to the company success.
EDUCATION
B. S. Chemical Engineering
University of Puerto Rico, Mayagüez Campus
Graduation Date: May 2007
Minor: Environmental
EXPERIENCE
March 2010 to Present Eli Lilly & Co; Carolina, PR
SOP Writer
• Responsible for the verification and correction of SOP’s, Training Materials and others.
• Participation during the development process of training material and/or training process.
• Evaluate the necessity of learning interventions to assure the effectively of the learning process.
• Evaluate the content and format of the developed documents.
• Perform interviews related to the content and effectively of the learning process.
• Develop documents based on the evaluation and interviews performed for that purpose.
• Participate, assist and provide the location of information required during inspection periods or audits concerned.
• Plan and coordinate with areas supervision the intervention windows for the knowledge transfer process.
• Manage multiple project and documents completion in accordance with established timelines.
June 2007 to Feb 2010 Baxter Healthcare; Guayama, PR
Validation Specialist
• Responsible for the development and execution of Qualification Protocols (IQ/OQ/PQ) for Equipment, Facilities, Utilities, and Packaging equipment but not limited to Fill & Packaging Lines.
• Support to establish, implement and manage the Validation Program.
• Plan and coordinate validation activities / Manage multiple validation projects to provide documented evidence of validated submissions, equipment, control systems and manufacturing processes.
• Manage project completion in accordance with established timelines and provide completed validation documents suitable for review by regulatory agencies.
Summers 2003 and 2004 Bristol Myers Squibb; Barceloneta, PR
Production Line Operator
• Managed several equipments and boilers to maintain and supply heat or steam for marine vessels, buildings or operations of pneumatic tools.
• Responsible for checking daily logs that help to determine proper operation of equipment.
• Maintain equipment, floors, windows and tools are cleaned.
• Manage project completion in accordance with established timelines and provide completed validation documents suitable for review by regulatory agencies.
Undergraduate Researches:
Chemical Engineering Department, U.P.R., Mayagüez Campus
• August 2005: “Reliable Model using Solar Energy for the Operation of Common Appliances”; supervised by Prof. Federico Padrón.
• January 2004: “Structural tuning of Sulfonated Styrenic Tri-Block Copolymers with Supercritical Fluid Processing”; supervised by Prof. David Suleiman and MS Student Cenilda Ramírez.
• August 2003: “Recovery of Cadmium from Seawater Brine”; supervised by Prof. Federico Padrón and Participate in the Undergraduate Student Poster Competition of 2003 AIChE Annual Meeting in San Francisco, California.
PROFESSIONAL SUMMARY
Experienced in Microbiological Laboratory and Validation Activities.
Proficient in the use of Printers, Photocopiers, Microsoft Office, Windows, and searching tools as Internet Explorer.
Knowledge of cGMP's, and FDA Policies and Regulations.
Experience in the use of United States, Japanese and European Pharmacopoeia.
Effective Interpersonal and Teamwork skills.
Excellent problem solving techniques and analytical skills.
Fully Bilingual (Spanish / English).
Leadership and good communication skills.
SKILLS
Computer literate: MS Office/Windows, Mathlab, C++, Trackwise, Leads, SAP and Regulus. cGMP’s, FDA Regulations, responsible, teamwork oriented, honest and self started. Validations & Qualifications experience including Commissioning, IQ/OQ/PQ Protocol & Final Report execution, closure and SOP's.
REFERENCES
Available upon request.
Contact this candidate