m
mayttetoro

May

@mayttetoro

CSV Project Engineer

Porto Rico
Certaines informations sont présentées en anglais.
À propos de moi
Hi, I'm May! I'm 27, and I turn complicated systems into documentation people actually understand. I've developed Computer Systems documents on 20+ projects, consistently meeting deadlines in regulated environments. Most technical docs fall into one of two traps: too dense for teams to follow, or too loose to survive an audit. Software systems are usually only understood by the engineers who built them, that gap is where I come in. I translate complex systems into documentation that's clear and audit-ready. Let's get to work. 🚀... Plus d’infos

Compétences

m
mayttetoro
May
hors ligne • 
Temps de réponse moyen de 4 heures

Voir mes services

Rédaction technique
I will create software and app documents
De110 $US / projetPlus de détails

Portfolio

Expérience professionnelle

Johnson_& Johnson

CSV Project Engineer

Johnson & Johnson • Temps plein

Apr 2023 - Jun 2026 • 3 yrs 2 mos

CSV Project Engineer supporting Johnson & Johnson's Janssen facility, ensuring computer-based systems for Good Manufacturing Practice operations meet FDA regulatory requirements. Specialized in developing, updating, and routing regulated technical documentation, including Software Design Specification, Hardware Design Specification, User Requirement Specifications, Test Methods, Risk Assessments, Standard Operating Procedures, Work Instructions, and more, across complex validation and qualification projects. Led documentation and validation support across 20+ projects over three years, including control system upgrades, enhancements, modifications, and equipment commissioning initiatives. Collaborated cross-functionally with engineering, automation, and quality teams to ensure documentation stayed accurate as systems and processes evolved. Skilled in translating complex, engineer-level system knowledge into clear, actionable documentation that regulated teams can follow with confidence, and that holds up under regulatory audit. Key strengths: technical writing, regulatory documentation (FDA, GMP, GDP), process mapping and flowcharts (Microsoft Visio), computer systems validation, and cross-departmental coordination in high-compliance environments.