Mes Validation Specialis
MES Rockwell Pharma Suit Validation Activities. IQ, OQ, Closing Reports. Work Instructions.
Dec 2022 - Mar 2023
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Maritza C. Email & Phone Number
Validation Consultant
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✓ Verified Jun 2026
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Role
Validation Consultant
Location
Daytona Beach, Florida, United States
Who is Maritza C.? Overview
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Maritza C. is listed as Validation Consultant based in Daytona Beach, Florida, United States. AeroLeads shows a matched LinkedIn profile for Maritza C..
Maritza C. previously worked as MES Validation Specialis at Bbraun and MES Designer at Merck. Maritza C. holds Mba -, Systems Information Management from Universidad Del Sagrado Corazón.
Profile bio
About Maritza C.
MES Pas-X, UAT, High Sheer Granulator, Processes, HPLC Instrument, TOC & GC, Spectroscopy, TOC Instrument, Equipment Validation –Wyeth Pharmaceutical Guayama, Merck, Las Piedras. Ability to work in teams. Knowledge in the following ERP system: MES Pas-X, SAP FI, PP, MM, Explorer, SDLC. Computer languages: RPG400, RPGLE, Java, Access, COBOL, Foxpro, MS SQL, Visual Basic, MAPICS, JD Edward. Operating Systems: Novel, AS400, Windows Server 2003 & Windows NT. Systems Utilities: MS Office, Visio, MS Project, Bar Code programming experience. Certified in Fundamentals of Biotechnology Manufacturing. Training in GMP, Computer Systems Validation (CSV- SDLC,IQ,PQ,OQ) and 21 CFR Part 11 Electronic Record & Electronic Signature Courses of Business Administrations: Accounting, IS Management, Statistics, Economy Validation on: CSV, Facilities, Utilities, Packaging, including: Manufacturing Equipment: OPC Server, Coater Tablet Accelacota, Hi Sheer Granulator, IBC Washer Portable sieve, low head room hoist, Down Flow Booth, Drum Tipper, Ultrasonic Washer, Vacuum transfer system, Suspension Tanks, Deduster and Metal Checker, Tablet Film Coater, portable Peristaltic pumps, and Cleaning. QBMS, SAP FI: General Ledger, Account Payable, Account Receivable, SAP PP, MM and Explorer Modules. MES Pas-X MOs generation, process recipe development, equipment setting and material SAP interfaces. CSV Assessments for Manufacturing Equipment at Cordis LLC. This included the revision of existing Validation Protocols in order to find opportunities and remedies for them. Risk Assessments, Test Scripts, Traceability Matrixes and System Requirements were developed during remedies exercises. Systems software: Temp Tale Manager, Spray Coat System, Empower and Data Net Supervisor. Work in Schering Plough Pharmaceutical with the validation of lab Instruments. Understanding of how to conducts: SDS Page, Buffer preparation, ELISA & Concentration determination.
12 roles · 31 years
Maritza C. work experience
A career timeline built from the work history available for this profile.
Mes Designer
Trouble shutting during different biotechnology manufacturing activities operations in the Implementation of Werum Pas X MES. The biotechnology manufacturing process included the following rooms operations: Buffers preparation, Columns, Yeast Harvest, Fermentations and Bioreactors. Providing MES operations support during manufacturing biotechnology.
Aug 2021 - Mar 2022
Validation Scientist
Preparing CSV Qualification Protocols and System Operating Procedure for AXIMA Confidence IR Mass Spectrometer with AXIMA ID PLUS Microbial identification instrument. Developing validation deliverable: Risk Assessment, URS, SDS, FDS, IOQ, PQ and protocols executions.
Sep 2018 - Feb 2019
Senior Scientist
Preparing Qualifications Protocols and Systems Operating Procedures for manufacturing equipment as Kason Drum Sifter, Kason Vibroscreen Separator, Quadro Comil Mills, Drum Lifter, and Glatt Dryer.
Jan 2018 - Mar 2018
Fema Inspector
Wsp Inspector Services
Inspecting affected infrastructures by hurricanes Irma and Maria. Inspected damages homes of hurricanes victims in Puerto Rico, visiting FEMA applicants in different towns, evaluated and documented dwellings damages
Nov 2017 - Jan 2018
Validation Specialist
Validation Specialist Medical Device CSV qualification at Zimmer Biomet, Ponce. Included Pre-qualification protocols, IQ, OQ and PQ protocols generations and execution for Manufacturing Equipment Software.
Jun 2016 - Sep 2016
Senior Regulatory Consultant
Spreadsheet Validation that included the Risk Assessment, System Design Specification, Traceability Matrix, IQ, OQ and PQ deliverables generation. Execution of the Qualifications Protocols for laboratory spreadsheet.
Apr 2015 - Dec 2015
Mar 2013 - Jan 2014
Regulatory Compliance Specialist
Developed Risk Assessment, User Requirements Specifications(URS) and IOQ Protocol for Manufacturing Area potable water heater at Novartis Pharmaceutical, Humacao site. Develop User Acceptance Test (UAT) activities at McNeil Pharmaceutical, Las Piedras site. Prepare UAT deliverables for CSV manufacturing processes. Prepare Pas-X successful Process.
Mar 2010 - Feb 2012
Validation Engineer At Wyeth (Guayama Pharmaceutical Site)
Commissioning projects activities at Wyeth Pharmaceutical, Guayama site. Include commissioning and qualification project activities developing and executing of SAT, IOQ protocols for QBMS(Quality Building Management System). Perform Utilities test in order to develop facilities validations deliverables. Developing and executing of OPC Server and IBC.
Jul 2006 - Nov 2007
Validation Consultant
Shering Plaugh Pharmaceutical
Schering Plough - Participated in validation of the ONIC FT-IR laboratory equipment application software as part of their Part 11 remedies plan. Responsible in developing of software administration SOPs, runs protocols dry runs and its executions. Cordis - Working in the TempTale manager, Spray Coating System, Data Net Supervisor and Spreadsheets. These.
Jun 2004 - Feb 2006
Programmer/System Analyst Rpg-As400
Responsible of application’s developing projects in the AS400 system. Worked with QUERIES, DFU, SDA, RLU, PDM, CL & RPGLE. Worked with the analysis, design, programming, systems documentation including system validation, implementation and maintenance of these projects. Provide supports to users with AS400 applications including MAPICS, Windows Server 2000.
1995 - 2002
~7 yrs
3 education records
Maritza C. education
Mba -, Systems Information Management
Certificaiton, Industry Biotechnology Technics
Bs, Computational Mathematics
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What is Maritza C.'s role at their current company?
Maritza C. is listed as Validation Consultant.
Where is Maritza C. based?
Maritza C. is based in Daytona Beach, Florida, United States.
What companies has Maritza C. worked for?
Maritza C. has worked for Bbraun, Merck, Bristol-Myers Squibb, Avara Pharmaceutical Services, and Wsp Inspector Services.
How can I contact Maritza C.?
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What schools did Maritza C. attend?
Maritza C. holds Mba -, Systems Information Management from Universidad Del Sagrado Corazón.
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