Annette Alanis
Commissioning, Qualification, and Validation (Cqv) Engineer @CAI
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WORK HISTORY
Commissioning, Qualification, and Validation (Cqv) Engineer @CAI
Houston, TX, US
Provides commissioning, qualification, validation, start-up, project management, and other consulting services associated with operational readiness to FDA-regulated and mission-critical industries. Led process improvement and validation projects for FDA-regulated pharmaceutical facilities. Conducted root cause analysis, risk assessments, and developed process engineering strategies for operational readiness. Trained and mentored clients in regulatory compliance, SOP development, and process documentation.
EDUCATION
Texas A&M University
Bachelor of Science - BS, Biomedical/Medical Engineering
Idea College Preparatory Mission
High School Diploma
Texas A&M University
Master of Engineering - MEng, Engineering/Industrial Management
ABOUT ANNETTE ALANIS
Howdy! I’m a Project Engineer with 4+ years of experience supporting CQV, validation, and continuous improvement projects for FDA-regulated pharmaceutical and biotech companies. With a background in Biomedical Engineering and a master’s in Engineering Management, I combine hands-on technical knowledge with strategic thinking to lead cross-functional teams through process redesigns and system optimization initiatives.I’ve managed complex projects across multiple high-impact environments—helping organizations like ICU Medical, Eli Lilly, Thermo Fisher, VGXI, and Empower Pharmacy ensure operational readiness and compliance. My work has included authoring SOPs, performing risk assessments, qualifying systems (IQ/OQ/PQ), and using Lean and statistical tools to identify inefficiencies and implement effective solutions.Whether I’m leading a large-scale manufacturing improvement or optimizing autoclave cycles with biostatistics, my focus is always on delivering safe, compliant, and efficient results. I pride myself on being a strong communicator and proactive problem solver who can drive transformation from the ground up.o Key Skills: Lean Manufacturing • Validation & Qualification • Process Improvement • Risk Assessment • FDA & cGMP Complianceo Tools: MATLAB • Minitab • AutoCAD • SolidWorks • Python • Microsoft Officeo Certifications: CSA & CSV (KENX) • Ethical Leadership (TAMU)o Languages: English (Fluent), Spanish (Conversational)Let’s connect if you’re focused on engineering excellence, continuous improvement, or transformation in healthcare and life sciences.
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