Joe Denver Email & Phone Number

York, PA, US

St. Paul, MN, US

Westlake Village, California, US

Write and execute AIC and AIOQ BAS protocols.Perform loop testing and alarm testing for Siemens BAS equipment.Write and file exception reports with root cause and corrective action analysis.Ensure equipment specifications and operations are successful.Perform drawing verifications.

Barrington, IL, US

Mainz, DE

Wrote supervised and documented OQ PQ and PV documents. Worked with QA, QC and production to accomplish assignments on tight deadlines and scheduling.

Waltham, MA, US

Setup and Implement and administer the Maximo PM system to replace handwritten logbooks and records. Learned Solidworks and ECO process.

Raleigh, North Carolina, US

DQ IQ OQ warehouse storage

Quality Control to oversee 3rd party vendor activities.

US

Verification Activities, Moved to remediation activities.

Paris, France, FR

contracted through Azzur

Rockville, MD, US

Kaye Validation mapping CTUs

Write and Execute Commissioning and IOQ Genesis Capper.

New York, New York, US

Change Control, Wrote, reviewed edited and executed IOQs and final reports for Downflow Booth and warehouse.

Basel, CH

Wrote, reviewed edited and executed SaniMatic CIP Skid Protocols and Sievers TOC IOQ Final reports. Executed HVAC and tank IQ OQ Reviewed TOPs Of all Media systems.

Write, review and execute Automation PCS PLC IOQ protocols. Coordinate FAT document reviews and execution. Report meetings, track and report progress and support production startup.

Executed IO and OQ on ABEC bioreactor/fermentors and inactivation tanks

Executed HVAC Commissioning and equipment protocols. Worked with Pall executing IOQs on filter integrity testers. Executed commissioning and IOQ on Satorius ultrafiltration skid and reviewed vendor documents. Executed and reviewed Alpha Wassermann centrifuge commissioning documents. Wrote and executed eppendorf and Jouan lab centrifuge IOQ’s Wrote and.

Wrote and executed IQP documentation for medical device specialized process manufacturing equipment including swaging and extrusion equipment, sealers, packaging equipment, printers and other COTS equipment. Incorporated legacy documentation and drawings for in-house-built or modified manufacturing equipment.

Wrote and executed Equipment Qualification Protocols. (Vessels: bioreactors and storage tanks. Cold storage units and incubators. Compressed gas systems) CIP and SIP Protocol Execution.

Wrote and executed ERS and IOQ documentation for medical device process manufacturing (Extrusion) Equipment including water baths, air boxes, printers and software and controllers and gradient system

Thermal mapping –80 freezers, verify and redline drawings WFI and CA, executed IQOQ equipment protocols, incubator shakers; reviewed and approved cGMP documents.

Autoclave validation, thermal mapping.

 Performed autoclave temperature mapping tests and PQ execution at Bard BioPharma LP - Princeton, NJ. Wrote and executed IQ, OQ, and PQ protocols using turn over package for RO/DI water system. Performed temperature studies and temperature mapping tests. Utilized 100 data loggers for maximum efficiency mapping and qualifying multiple storage areas..

Computer Networking

Solidworks

Bs, Env Chemistry