Twenty years of experience in the areas of Medical Device, Pharmaceutical, Electrical Control, Electronics, and Air Compressor industries. Strong engineering experience in both Process and Equipment validation.
Titles Held: Senior Validation Engineer; Project Manager; Principle Engineer; Senior Manufacturing Engineer; Senior Mechanical Engineer
- Experience with new product introductions; mechanical designs; line relocation and start-up
- Equipment installation, validation protocol creation and execution and operator training
- Hands-on experience with high-vacuum/high-temperature equipment, high-pressure hydraulic systems, high-pressure air systems, clean rooms and equipment, and high-volume aqueous washing and solvent washing/degreasing systems
- Expert in designing, implementing, and executing FAT, IQ, OQ, PQ, and PV protocols
- Experience with Class II and Class III medical devices