Mikayla Oneill

Background

About Mikayla Oneill

I am currently a Project Engineer at Precision for Medicine. Precision covers the globe, supporting trials at every stage. From early development to regulatory approval, from sea to sea, Precision is a global partner to many of the most innovative life-sciences companies in the world. We partner with our clients to safely deliver ground-breaking treatments to patients.​ My background consists of an education in Biomedical Engineering, which I have been able to leverage in past roles and my current position. I pride myself in being skilled in Good Documentation Practices (GDP) within cGMP settings, ensuring meticulous record-keeping and compliance adherence crucial for regulatory standards within the pharmaceutical and medical technology sector. Additionally, I am proficient in developing Validation Lifecycle documents, leveraging expertise in User Requirement Specifications, Commissioning, Installation Qualification, Operational Qualification, and Quality Summary Reports under guidance from CQ Leads and SMEs. I am also adept at supporting process optimization through the development of Standard Operating Procedures (SOPs), enhancing operational efficiency and maintaining strict timelines in critical project environments.