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
