Steve Green Email & Phone Number

• Sr. CQT Consultant 7/2014 – 10/2014
• Created procedures to industry best practice and compliance for the validation program for a North Central medical device manufacturer.
• Created templates for execution of the validation program.Sr. CQT Consultant 12/2013 – 6/2014
• Validation Engineer for Extrusion Line production of tubing products for a North Central medical device company.
• Integral member of a five person team providing installation, operational qualification of existing equipment and Process Qualification and Process Performance Qualification resulting in the generation of over 100.
• Assisted in the execution and summary of Molding Extrusion PPQ protocols.Sr. CQT Consultant 04/2012 – 11/22/13

• Project leader for the validation relating to new product launches including process validation, cleaning validation and packaging validation.
• Provided manufacturing assistance with the technology transfer of new products from Development to commercial production.
• Defined and validated the manufacturing processes for mixing, coating, fabricating and packaging of new product launches.
• Supervisory responsibility for Pharmaceutical Technology team.
• Provided documentation to Regulatory Affairs for the CMC section of new NDA/ANDA filings.
• Assisted in the design, function, acceptance and validation of new processing equipment.

Facilities qualification, commercial equipment qualification, cleaning validation, process validation and production support.

Machine Qualification, scale up and Process Validation of development products to commercial manufacture. In addition Cleaning Validation of commercial equipment and facilities.

Wrote and executed validation documentation for the IQ / OQ / PQ of existing pieces of production equipment for commercial manufacturing. Wrote and executed validation documentation for process and cleaning procedures. Performed and documented analysis on finished products for commercial product release using qualified analytical methods. Setup, calibrated.