Annette Alanis

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.

Experience

1. Commissioning, Qualification, and Validation (Cqv) Engineer

   CAI

   Jun 2021 — Present · 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

  2012 — 2016

• Texas A&M University

  Master of Engineering - MEng, Engineering/Industrial Management