Todd Dean Email & Phone Number

New York, Ny, Us

Commissioning qualification and validation activities within the pharmaceutical industry. I am currently working at a new site that is being developed. My primary focus is Fill Finish. All aspects of CQV activities from documentation, protocols, testing, validation, verification. IQ, OQ, PQ.

Ingelheim Am Rhein, Rhineland-Palatinate, De

• Responsible for vial sterilization washer and tunnel, aseptic filling, component preparation, capping and lyophilizing process. • Use Bosch and Bausch + Stroebel equipment for sterilization, filling and capping activities.• Experience with Modus and Telstar process control equipment for filling process.• Responsibility for maintenance of atypical processes of production equipment and facilities.• Responsible for cleaning of equipment using SIP, CIP and Autoclave according to cGMP.• Work in strict accordance of cGMP and GDP practices.• Work in a controlled environment by adhering to the regulatory requirements by the USDA.• Work on current verification activities as needed. • Assist in training new employees.

Tokyo, Jp

• Troubleshot and identified uncharacteristic processing conditions and automation holds during commissioning and validation activities.• EBM field testing with DeltaV on manufacturing processes during validation activities.• Conducted testing on COP Glass Washers to determine recipe parameters.• Performed purification process work-orders for EBM developers to test new modifications.• Worked with controllers, indicators, control valves, PLC, analyzers, sensors, pumps, pH and conductivity meters.• Prepared media and buffer solutions using various chemicals as batch requirements.• Documented and executed commissioning activities for CIP systems.• Performed UFDF - ultra filtration and diafiltration systems requirements.• Operated Clean-in-Place (CIP) and Clean-out-of-Place (COP) systems for cleaning of production equipment.• Assembled, operated and tested filtration systems (Nano and Cuno).• Conducted gold nanoparticle testing for viral nanofilter integrity.• Executed equipment module testing and documentation for project substantial completion.• Monitored and recorded critical process parameters.• Provided a moderate level of troubleshooting, diagnostic and repair of critical equipment including but not limited to precipitate vessels and CIP/COP systems.• Perform testing and sampling using aseptic techniques.

Richardson, Tx, Us

• Performed the month-end revenue close and executive level financial reports. • Responsible for analyzing all results and explaining variances to subsequent month, forecast, and plan to the Business Markets Controller. • Created and presented the monthly consolidated reporting and analysis for all products by sub segment. • Developed models using internal Data-warehousing system to build reporting on product rate and volume variances and trend analysis. • Performed detailed statistical analysis to develop revenue recognition methodology. • Implemented Rate, Volume, and Mix analysis into the monthly reporting to assist Close Group in explaining segment results. • Forecasted monthly contract credit activity to determine adequate Balance Sheet Reserves. • Prepared monthly Business Operations Review and conducted conference with the segment to discuss analysis. • Actively participated in monthly billing presentation to discuss issues that drive billing inconsistencies across business segments.