Chemical Engineer
Resume:
Alicia I. Meléndez Vega
PO Box **** Arecibo, Puerto Rico 00613
********************@*******.***
Summary of Qualifications
• B.S. on Chemical Engineering Graduated at University of Puerto Rico-Mayagüez Campus with 5 years of cross functional experience in the Pharmaceutical and Chemical Industries as Manufacturing Supervisor and Validation Specialist.
• Knowledge generating and updating Manufacturing Batch Records, SOP’s, Work Instructions, Cleaning Batch Record, Change Request, OSIL’s, LDAR Reports and MOC’s. Hands on experienced in bulk process operation, chemical processes management and hazardous materials handling.
• Strong expertise developing automation-related validation documents such as, User Requirement Specifications (URS), IQ, OQ, PQ and Validations Reports.
• Knowledge in project cost analysis in order to determine the cost effectiveness of projects. Perform site evaluation and flow diagram to determinate process changes affected by the projects.
• Vast experienced providing technical training to plant personnel (team leaders and chemical operators).
• Developed key performance indicators (KPI) to have manufacturing people focused on critical parameters to ensure the sustainability and process control, by using statistical approach. Strong expertise in cleaning validations, internal and documentation audits.
• Exposed and knowledge on hazardous waste inspections. Environmental, Health and Safety regulations knowledge.
• Six Sigma, Lean Manufacturing, Delta V and PROVOX system knowledge. Computer literate with strong knowledge in Track Wise, Time Attendance-Kronos and ARS.
• Ability to perform multiple tasks in a high pressure environment with minimum supervision. Quality and team work oriented. Responsible, reliable, pro-active, initiative, quick learner, innovative decision maker with strong problem solving skills. Excellent interpersonal and communication skills. Bilingual in Spanish and English.
Accomplishments
• Managed and monitored diverse plant parameters identifying bottleneck of the process and improved, providing significant saving (700K) and improved efficiency on the process.
• Participate as a key player in a cleaning validation process, issuing the cleaning forms reaching the companies objectives and saving a significant amount of money.
• Participated in a solvent recovery project modifying the MBR’s to assure the proper segregation of solvent obtaining a significant saving in the solvent disposing.
• Perform process optimizations reduce cycle times in different stage (i.e. Cycle time reduction of 64% in the centrifugation and 50% in the drying stage of the Reyataz process).
• Lead the manufacturing team in charge of the P&ID revision and corrections as part of the Engineering and Validation activities to support Atazanavir Sulfate capability project. Also, in conjunction with the Validation Group worked in the creation of procedure and work instruction of new and modified equipments as part of this project; and provide training to the personnel.
• Actively participated during the closure process of a pharmaceutical plant assuring all activities complied with regulatory requirements.
Professional Experience
Excellence Project Management - Pfizer, Barceloneta Puerto Rico
API Specialist 2008 - 2009
Perform a site evaluation and a Value Stream Map of the facility, determine the process changes and modify the SOP’s during an Automation Project. Responsible of define process flow for API, Quality and Automation. Develop a cost analysis evaluation of a process to determine the cost effectiveness of a future project. Perform a site flow diagram and a GAP Analysis of the future vs. actual process flow to identify the tasks affected in the project. Provide support during a project validation developing automaton-related validation documents for the “Management Automation Initiative (Catalyst) Project”. To develop and modify SOP’s and validation documents such as, User Requirement Specifications (URS), IQ, OQ, PQ and Validations Reports.
Bristol Myers Squibb, Barceloneta Puerto Rico
Manufacturing Supervisor 2005 - 2008
Provided support to the manufacturing process to achieve operating goals that included the manufacture of three bulk actives and two intermediates. Provided direct supervision up to 8 Chemical Operators in a five-shift operation ensuring the shift operations of the manufacturing process and related activities were properly coordinated. Lead and coordinated process operations like reaction, distillation, crystallization, isolation, drying, milling and cleaning to achieve production requirements assuring that all safety requirements as PPE, Work Permits were followed. Committed with the daily production, volume, quality and the integrity of the product assuring that all procedures, SOP,s and MBR,s were followed and requested all the necessary maintenance requirements to assure the highest efficiency of the equipment. Identified and resolved problems during production. Assured all procedures were performed following the cGMP’s and safety procedures of the company. Worked to minimizes scrap and to avoid process deviations. Assured that process deviations were properly investigated using Trackwise program through investigation report and CAPA’s implementation. Assured the documentation was updated and the personnel were properly trained (“qualified”) to perform their tasks.
Enviro-Safety Compliance Inc Guaynabo, Puerto Rico
Environmental Specialist 2004 – 2005
Identified and documented environmental compliance issues in diverse facilities. Conducted hazardous waste inspections and provided recommendations for corrective actions. Performed hazardous material inventories and regulatory reports for facilities.
Education
University of Puerto Rico, Mayagüez Puerto Rico
Bachelor Degree in Chemical Engineering
Seminars and Trainings
• Process Cleaning and Water System Validation
• Hazardous Permit and Hazmat Training
• Fire Brigade, Confined Space Rescue and CPR Training
• Train the Trainer Certificate
• Environmental Regulations and Permits
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