I specialize in process equipment qualification and computer systems validation for biotech, pharmaceutical, and medical device manufacturers. With over 20 years of hands-on experience, I deliver efficient, audit-ready deliverables packages that align with regulatory requirements and operational goals.

 

I work directly with clients to provide tailored, GxP-compliant support — from the configuration and validation of complex software platforms to the commissioning and qualification of high-value manufacturing equipment for drug and device manufacturing. 

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​​As a one-person consultancy, I combine technical leadership with a meticulous attention to detail — helping teams navigate complex compliance challenges while driving project momentum. ​I’m not a firm. I’m not a staffing agency. I’m a freelance validation expert who shows up, integrates quickly with your business processes, and delivers optimal outcomes with confidence and efficiency.​

 

If you’re looking for a reliable partner who works independently, communicates clearly, and understands the realities of regulated manufacturing, let’s connect.