Over 29 years of process and project engineering experience, with over 27 in the Pharmaceutical/Biotech/Medical Device industry; biotechnology, oral solid dose, liquid dosage and primary/secondary packaging. Proven successful in delivering on-time projects with good results, Manufacturing and customer oriented. Extensive experience with Validation and document writing. Hands-on technical expertise with equipment and operations. Management of Capital projects for new equipment and modifications to existing equipment and areas.

Specialties: Project management, Process engineering, hands-on manufacturing experience, leading risk assessments, lean manufacturing, Risk-Based approach to validation, equipment specification, equipment trouble-shooting, document writing (SOP, Batch Record, Validation), Aseptic Manufacturing/Filling, Medical Device, Biotechnology, Liquid manufacturing, Oral Solid Dose manufacturing, Compound Pharmacy regulatory compliance, aerosol manufacturing and packaging in all of the areas listed above.