Génesis Marrero

Determined Validation Engineer with over 9+ 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.

SR. VALIDATION ENGINEER - Samsung Biologics - Rockville, MD

(2026-04)

• Lead lifecycle equipment and cleaning validation (IQ/OQ/PQ) for GMP systems, ensuring compliance with global regulatory requirements (FDA/EMA)
• Develop and execute Cleaning Validation Master Plans (CVMPs), protocols, and reports for multi-product biologics manufacturing
• Design, qualify, and optimize CIP/SIP systems, improving cycle efficiency while maintaining validated state
• Perform risk assessments (FMEA/ICH Q9) to define worst-case conditions, acceptance criteria, and validation strategies
• Establish scientifically justified residue limits (MACO, HBEL/PDE) and sampling approaches (swab/rinse recovery)
• Lead deviations, investigations, and impact assessments, implementing effective CAPAs to prevent recurrence
• Author and review validation deliverables in Veeva/Kneat, ensuring data integrity and ALCOA+ compliance
• Support equipment qualification (bioreactors, filtration, chromatography, autoclaves) and facility expansions/NPI
• Collaborate cross-functionally with other groups to drive validation readiness
• Act as SME for cleaning validation during audits and regulatory inspections, supporting inspection readiness
• Identify and implement process improvements to enhance throughput, reduce cycle times, and minimize deviations

SR. VALIDATION ENGINEER - GSK

(2019-11 - 2026-03)

SR. VALIDATION SCIENTIST - AMGEN Manufacturing Limited with ECHO Consulting Group / PharmaLex - Juncos, PR

(2018-03 - 2019-11)

• Optimized CIP cycles, reducing cleaning time and resource usage while maintaining action
• Development and review of procedures of compliance 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
• 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 - Las Piedras, PR

(2017-05 - 2018-03)

• 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

MS / MBA Dual Master's - Pharmaceutical Manufacturing - Stevens Institute of Technology (2026-05) Hoboken, NJ

Bachelor of Science - Microbiology - University of Puerto Rico (2019-12) Humacao, PR