Jayen Diyora
Director, Manufacturing Validation
- Role
- Director, Manufacturing Validation at Stoke Therapeutics
- Location
- Hillsborough, NJ, US
- LinkedIn followers
- 500 followers
About Jayen Diyora
Experienced and accomplished validation engineer with twelve (12) years of experience in supporting the validation of equipment, facilities, and utilities in biopharmaceutical industries. Extensive experience in working closely with manufacturing operations, process engineers, Quality control, and Quality Assurance group to ensure a continuous culture of achieving intended compliance and quality expectations. Completed Master’s in Engineering Management while working full time and acquired effective communication, teamwork, project management, time management, prioritization, problem, and conflict resolution skills. Core competencies and accomplishments include:• Act as Site Lead• Performed Process Performance Validations• Validation Project Plan and Reports• Validation lifecycle per Quality expectations• Leading complex validation projects • Cleaning validation SME• TOC analysis SME• Sterilization validation SME• Analytical Method validation• Knowledge of Computer systems, Transportation, and medical device Validation • Knowledge of Quality Management Systems, including risk management• Change Control Impact Assessment• Corrective and Preventive action impact assessment• Investigation and Root Cause analysis• Kaye Validator Data trace probes, Ellabs probes• Science and risk-based approaches such as FMEA, PAT, Design of Experiment, and other statistical tools and analysis• Supported and Participated in Regulatory Inspections
Experience
Director, Manufacturing Validation
Mar 2025 — Present
Education
Soniya Education Trust College of Pharmacy,Dharwad,Karnataka
Bachelor's degree, Pharmacy
2003 — 2007
Rajiv Gandhi University of Health Sciences
B-pharma, pharmacy
2003 — 2007
Tufts University
Master's degree, Engineering Management
2017 — 2019
Stevens Institute of Technology
Master's degree, Pharmaceutical manufacturing
2008 — 2010
Skills
- Capa
- Glp
- Quality Assurance
- Sop
- Fda
- Protocol
- Hplc
- Validation
- Microbiology
- Gxp
- Quality Control
- Gmp
- Change Control
- 21 Cfr Part 11
- Cleaning Validation
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