Lead a business unit of verification and validation engineers, including all relevant sales and account management, team and project management, and communication of business unit status to various levels of the company.Performed design verification for medical device software including database generation and testing, firmware interaction, change management, source code reviews and protocol generation and review.Performed validation of food and beverage as well as pharma… Show more Lead a business unit of verification and validation engineers, including all relevant sales and account management, team and project management, and communication of business unit status to various levels of the company.Performed design verification for medical device software including database generation and testing, firmware interaction, change management, source code reviews and protocol generation and review.Performed validation of food and beverage as well as pharma manufacturing equipment. Show less

Developed and implemented a preventive maintenance and calibration program for the entire business from the ground up.Developed or aided in the development of all validation efforts for the business. Includes all equipment qualification, commissioning (from date of hire), and process validation activities.Developed several SOPs and provided QA review of a large number of cGMP documents such as batch records, SOPs, deviation & change control documents, and cGMP… Show more Developed and implemented a preventive maintenance and calibration program for the entire business from the ground up.Developed or aided in the development of all validation efforts for the business. Includes all equipment qualification, commissioning (from date of hire), and process validation activities.Developed several SOPs and provided QA review of a large number of cGMP documents such as batch records, SOPs, deviation & change control documents, and cGMP audits.Provided troubleshooting and corrective action for several facility systems, including HVAC systems, lab water purification systems, and temperature and humidity controlled stability chambers. Also modified design and managed installation of changes to these systems in order to better meet facility needs. Show less

Performed validation work for HVAC systems at a well known large pharma company.Drafted design documents, functional specifications, and test protocols. Followed all documentation through execution and approval of validation packages.Worked on-site to commission a pharmaceutical facility outside the continental US.

Monitored system performance data for two 200+ MW steam turbine generators and made tuning changes to the associated control systems as necessary.Performed troubleshooting and made minor modifications for plant PLC-based systems.Calibrated and tested existing systems in the plant as well as the coal conveying system to ensure proper performance.Monitored plant emissions to ensure compliance with environmental regulations. Initiated purchasing and installation… Show more Monitored system performance data for two 200+ MW steam turbine generators and made tuning changes to the associated control systems as necessary.Performed troubleshooting and made minor modifications for plant PLC-based systems.Calibrated and tested existing systems in the plant as well as the coal conveying system to ensure proper performance.Monitored plant emissions to ensure compliance with environmental regulations. Initiated purchasing and installation projects for new equipment with budgets ranging from $100k-$500k. Show less