Providing CQV support services for client as part of Plant start up near the Lakeshore.

6+ years working within Consent Decree environment. Well versed in applicable federal guidelines and regulations, specifically cGMP 21 CFR Parts 210 & 211 and adherence to Standard Operating Procedure (SOP). FDA experience also includes – 483 & Warning Letter remediation and Consent Decree Post-Work Plan environments. Provided principal level leadership to the cleaning validation group at JJCI in Lancaster, including day to day supervision of engineering peers and contractors. Delivered compliant cleaning processes for equipment used in the manufacture and packaging of Imodium, Benadryl, and Pepcid products. Collaboration with CQV, process, and packaging disciplines in delivery of qualified/validated equipment, systems, and processes.

Successfully managed equipment cleaning processes across three (3) key manufacturing and packaging sites for more than a decade; this includes new product introductions and lifecycle maintenance of well over two-hundred NDA, ANDA, and Monograph OTC products (solid and liquid dose forms); including contract formulations for major pharma. Significant experience supporting several multi-million-dollar capital improvement projects from IOQ through commercialization – spray granulation and fluid bed dryer systems, homogenizing mixers, CIP cabinets, liquid bottling lines, etc. Actively involved in audit support, periodic monitoring, investigations and CAPA, process improvement, and project management. Technical lead, project manager, and key point of contact for assigned projects; provided day to day direction and tactical guidance for support staff. Also held the following roles: QA Validation II, QA Validation l, QA Validation Technician, and Ops Set-Up Technician / Shift Lead