Nicole Ramos Morales
Frederick,MD
Summary
Experienced Chemical Engineer with a demonstrated history in working in the biotechnology, pharmaceutical and petrochemical industry. Currently working as a Validation Engineer supporting many projects at different client sites. Experience working in a cGMP environment. Seeking a full time position and willing to relocate.
Overview
4
4
years of professional experience
Work History
Validation Engineer
PSC Biotech
Frederick, MD
11.2020 - Current
- Directed, coordinated, and supported validation activities while meeting client requirements and deadlines with minimum supervision.
- Authored and executed validation documentation (Commissioning Protocols, IQ, OQ, PQ, PPQ, Summary Reports) for various equipment such as refrigerators, freezers, incubators, environmental cabinets, floor and benchtop centrifuges, cell counters, rocker platforms, analytical balances, water baths, biosealer, tube welders and clean utilities at different client sites.
- Performed validation activities in a clean room environment.
- Performed empty and full chamber temperature mapping studies for temperature controlled units using wireless dataloggers and a KAYE Validator 2000 system.
- Trained team members in the use of temperature monitoring devices software's.
- Collaborated in the development of Validation Master Plans, Standard Operating Procedures, Maintenance Schedules, Equipment Manuals, Work Instructions and Specification Sheets.
- Led meetings with the client to discuss project status and roadblocks and made suggestions for issue resolution.
- Reviewed protocols, reports and data tables generated by peers and contract personnel.
Process Engineer
Technical Staffing Resources
Newark, DE
11.2019 - 07.2020
- Worked at KBR's Wilmington Operations Center (WOC) in a start up project as part of the Process Team in the design of a new PEMEX refinery in Mexico.
- Responsible for preparing data sheets for process equipment such as: Shell and Tube Heat Exchangers, Air Cooled Heat Exchangers, Stripping Columns, Pumps and Vessels.
- Generated Process Descriptions and Process Design Basis based on Licensor information.
- Developed Heat and Material Balances from ASPEN Hysis simulations of the plant.
- P&ID verification and markings for drawing corrections and updates in new revisions.
- Verified process documents were in accordance with PEMEX and Mexico Standards before issuing to client.
- Responsible for day to day contact with the client to ensure expectations were met.
- Served as translator in important meetings between the client and WOC office.
CQV Consultant Engineer
Biopharma Consulting JAD Group
Framingham, MA
09.2018 - 11.2019
- Performed Commissioning and Qualification activities for clean utilities systems, equipment and facilities for a start up project at Sanofi Genzyme.
- Authored and executed validation documentation (Commissioning Protocols, Summary Reports, IQ, OQ, PQ).
- Generated C&Q protocols using Kneat G7, a paperless and digitized validation software.
- Responsible for the execution of IOV, IOQ and final reports for Single-Use Totes, Single-Use Mixers, TCU's, Oxygen Gas System, CO2 Gas System, Nitrogen Gas System, Benchtop and Floor Scales, Freezers, Refrigerators, Downflow Booths and HVAC units.
- Performed risk assessments for the systems to determine associated risks and resulting activities per risk.
- Generated and supported the troubleshooting and close out of discrepancies and deviations.
- Conducted field inspections including piping, instrumentation and equipment walk downs.
- Executed temperature mapping of temperature control units using wireless data loggers.
Validation Consultant
Advanced Control Services Inc.
Vega Baja, PR
04.2018 - 08.2018
- Responsible for optimizing the Commissioning and Qualification documentation at Pfizer Vega Baja site.
- Created new validation forms and templates for clean utilities systems, equipment and facilities.
- Collaborated with the departments of Quality, Engineering, Automation and C&Q team with the creation of validation documents.
Education
Bachelor of Science - Chemical Engineering
University Of Puerto Rico - Mayaguez
Mayaguez, PR02.2018
Skills
- Industry Standard Knowledge
- Current Good Manufacturing Practices (CGMP)
- Equipment Calibration
- Computer Proficiency
- Planning and Coordination
- Project Management
- Leadership
- Team Player
- Effective Communication
- Active Listening
- Bilingual (English and Spanish)
- Work Under Pressure
- Problem Solver
- Data Analysis
- Critical Thinking
- Flexible & Adaptable
Timeline
Validation Engineer
PSC Biotech
11.2020 - Current
Process Engineer
Technical Staffing Resources
11.2019 - 07.2020
CQV Consultant Engineer
Biopharma Consulting JAD Group
09.2018 - 11.2019
Validation Consultant
Advanced Control Services Inc.
04.2018 - 08.2018
Bachelor of Science - Chemical Engineering
University Of Puerto Rico - Mayaguez
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