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 documents.• Assisted in the execution and summary of Molding Extrusion PPQ protocols.Sr. CQT Consultant 04/2012 – 11/22/13• Embedded Quality Engineer staff for review of change controls, validation documentation for a major Midwestern consumer healthcare product/pharmaceutical manufacturer.• Involvement in reviewing documentation for IQ, OQ, PQ and PPQ to assure all aspects of the validation program are present for solid dose and powder products.• Mentored new Quality Engineer staff on current trends in validation and specific topics for the site.CQT Validation Consultant Nov 2011 - Jan 2012• Reviewed and assessed current validation program for a major Midwestern consumer healthcare product/pharmaceutical manufacturer and reported the results of the assessment.• Revised procedures to industry best practice and compliance with new corporate procedures and FDA Guidance for Process Validation (Jan. 2011) for the validation program.• Performed gap analysis between corporate procedures and new procedures for the client.• Create templates for execution of the validation program.• Made recommendations for statistical techniques for validation that demonstrate the process can consistently produce product that meets predetermined specifications, including DOE for worst case validation, process optimization, and process capability.

• 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.• Wrote and performed Factory Acceptance Tests and Site Acceptance Tests for new equipment.• Troubleshot existing commercial product processes in the manufacturing facility.• Facilitated the introduction and validation of secondary suppliers for raw materials.

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 and documented new equipment for GC and HPLC analysis for the Quality Control laboratory.