Génesis Marrero-Pagán
Frederick,MD
Summary
Determined Validation Engineer with over 7+ years of developing and executing validation master plans in the Pharmaceutical/Biotech industry. Background authoring and approving validation protocols in addition to coordinating with other personnel to drive success. Stellar problem-solving, decision-making, and communication skills. Recognized within the organization as a Subject Matter Expert (SME) in Equipment and Cleaning validation.
Overview
7
7
years of professional experience
Work History
Validation Engineer
GlaxoSmithKline
11.2019 - Current
- Author and executioner of risk-based validation master plan and protocols such as Commissioning, IOQ, PQ, and RQ’s for manufacturing equipment: Manufacturing Tanks (Upstream/Downstream/Utilities), Incubators, Freezers, and Autoclaves, ensuring compliance with cGMPs; as part of the start-up of a mammalian biopharmaceutical facility with three value streams
- Create Final Reports summarizing execution protocols and support documents, writing deviations, and repeat test forms
- Author of Risk Assessments, Interim and Summary Reports
- Assembled and Reviewed Turnover Packages (TOPs) to verify all systems documentation was included and met the design specifications
- Coordinate, schedule, and execute validation activities and change controls, to ensure changes and requalification are consistent with regulatory standards and corporate requirements such as cGMP, 21 CFRs, and GAMP 5 guidelines
- Train junior validation engineers on validation protocol executions, good documentation practices (GDPs), TOP generation, and P&ID walkdowns
- Build and maintain successful cross-functional relationships with internal departments such as Manufacturing, Quality, Engineering, Scheduling, and QC Laboratories.
Sr. Validation Scientist
AMGEN Manufacturing Limited with ECHO Consulting Group / PharmaLex
03.2018 - 11.2019
- Cleaning Validations and Sterilization: Development and review of procedures of protocols
- Provide training to all the areas impacted by CIP Protocols
- Cleaning in Place (CIP) monitoring and execution activities according with the Master Plan
- Execute baseline and visual inspections
- Perform swab sampling on various systems of the manufacturing area
- Performed executions of Steam-In-Place (SIP) for Sanitization and Sterilization on various Process Qualification (PQ) protocols
- Generate reports with the results for the qualification of cleaning recipes in Cryovessels, Bioreactors, Centrifuge, PODS, Filtrate Hold Tanks, Retentate Tanks, Skids and Autoclaves on the Cell Culture, Harvest, Purification and BDS areas
- Team Lead of 3rd Shift with 3 people assigned, ensuring to coordinate, execute and successfully complete validation activities
- Train junior validation scientist on validation protocol executions, good documentation practices (GDP’s), etc
- Installation and handling of Biological Indicators (BI’s)
- Performed Calibrations for the Kaye Validator working with the Thermocouples (TC’s) and Intelligence Resistant Temperature Device (IRTD’s)
- Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Quality and QC Laboratories
- Coordinate information flow within client, contractors, and project team to ensure timely completion of assigned tasks
- Lead Qualification Team (5 Resources) assigned.
Cleaning Validation Scientist
McNeil Consumer HealthCare LLC by Johnson & Johnson with FIT’s
05.2017 - 03.2018
- Assist the executions of experimental, cleaning development, verification and validation processes
- Assist visual and analytical sampling of cleaned equipment for manufacturing and packaging areas
- Create protocols, reports and SOP’s as Validation, Verification and Development
- Review and assess deviations associated with or impacting cleaning validation studies
- Disaster Start-Up Protocols and Reports
- Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Quality, Micro and Analytical Laboratories.
Education
Pharmaceutical Manufacturing MS / MBA Dual Master’s -
Stevens Institute of Technology
Hoboken, NJ12.2025
Bachelor of Science - Microbiology
University of Puerto Rico
Humacao, PR12.2019
Skills
- Equipment Calibration
- Effective Communication
- GAMP guidelines understanding
- Risk Assessment
- Strategic Planning
- Quality risk management
- Environmental monitoring
- Quality management systems
Abilities Skills Equipment
English, Spanish, Bilingual, True, True, True, True, True, Word, Excel, Power Point, Visio, Internet Navigation, Rockwell Automation, Kneat, DeltaV, QLIMS, ECMS, LES, SAP (MERP), Veeva (VQMS), IP2, Windows (versions 98, XP, Vista, Windows 7, 8, 10 and 11), iOS Apple System, Proper aseptic techniques, environmental and surface samplings, media preparations, dilution and solution preparations, Kaye Validator, Production Equipment (single-use bioreactors, bioreactors, media bag station, buffer and media prep tanks, harvest tanks, skids, columns, bulk tanks, portable tanks, ultra-filtration/diafiltration tanks, autoclaves, glass washers, incubators, freezers, refrigerators, etc.).
References
References available upon request.
Languages
Spanish
Native or Bilingual
English
Full Professional
Timeline
Validation Engineer
GlaxoSmithKline
11.2019 - Current
Sr. Validation Scientist
AMGEN Manufacturing Limited with ECHO Consulting Group / PharmaLex
03.2018 - 11.2019
Cleaning Validation Scientist
McNeil Consumer HealthCare LLC by Johnson & Johnson with FIT’s
05.2017 - 03.2018
Pharmaceutical Manufacturing MS / MBA Dual Master’s -
Stevens Institute of Technology
Bachelor of Science - Microbiology
University of Puerto Rico
Similar Profiles
Pranali M WaghmarePranali M Waghmare
Regulatory Specialist - Submission Coordinator at GlaxoSmithKlineRegulatory Specialist - Submission Coordinator at GlaxoSmithKline
KEVIN ODHIAMBOKEVIN ODHIAMBO
Expert Product Representative at GlaxosmithklineExpert Product Representative at Glaxosmithkline
Jackie Lynn HayJackie Lynn Hay
Senior Vaccine Account Executive at GlaxoSmithKlineSenior Vaccine Account Executive at GlaxoSmithKline