Industry Consultant & Project Manager

Project Responsibilities

• Provide Facilities, Equipment and Computer System Validation (CSV) /CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices: • Develop, Generate and execute Facilities and  Equipment Validation Documents (URS, FRS, FAT, SAT, IQ, OQ, PQ ) and Computer System Validation planning documents to manage CQV projects (VMP, FRS, DQ) using Good Documentation Practices (GDPs) • Investigate and resolve protocol exceptions or discrepancies • Develop technical reports and CSV summary reports • Startup equipment and systems in a safe and effective manner • Develop GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS and summary reports • Perform risk assessments and impact assessments • Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC (Air Balancing, Smoke Studies, Fill and Finish Validation) utilities, instrumentation, controls, and automation to support clients.
• Writing and executing Change Control Request (CCR), URS (User Requirement Specifications), Development of VMP, and develop DQ (Design Qualification Documents. Write and execute Equipment IQ, OQ, PD, PQ, and Computerized Systems validation protocols for manufacturing equipment, critical utilities, HVAC, BMS, BAS, vial washing, depyrogenation, fill-finish and Serialization packaging equipment.
• Proficient at Microsoft Outlook, Excel, and Word (Trackwise, SAP)

• Computer systems (PLCs, SCADA, DCS) experience with Allen Bradley, Delta V, SAP, MES.

• Manage Equipment and Instrument Calibration systems and ensure compliance with current health care regulations.

EXPERIENCE HIGHLIGHTS

Aprogen Inc.

Osong, South Korea 

March to Sept. 2019

Role: Consultant for Manufacturing/Automation  

Write Engineering and Computer Systems SOP’s for this start up Pharmaceutical Company. These SOP’s involves  Fermentation, Media Preparation, Harvest, Ultrafiltration, Sterilization, Purification, Vial Washing, Depyrogenation Tunnel, Filling, Finishing and Packaging Equipment including its associated Process Control Systems.

Facilities SOP’s includes HVAC, BMS, EMS, Critical Utilities (Purified Water, WFI Generation, Storage and Distribution Systems, Specialty Gases) and Laboratory Equipment.

Pfizer Inc.

Chennai, India 

Sept 2018 to Dec. 2018

Role: Manufacturing/Automation /Calibration Project Manager

Managed and Conducted Computer Systems Gap Assessment for Data Integrity and assisted the operations teams (QA, QC, Production, Engineering, Maintenance) in and /or performing Non-Conformance of manufactured products possibly due to instrument calibration failure. This position required field investigation, gap assessments of facilities equipment computer systems used on the manufacturing equipment on the manufacturing floor, critical utilities such as Potable water, ROW, PW, WFI, PSG systems, and Warehouses.

Management of Calibration contractors and Equipment manufacturers scheduled maintenance and validation.

Regeneron  Company

Albany, New York

Apr 2018 to July 2018

• Quality Systems-Deviation-Investigations on Manufacturing equipment-instrument calibration and Computer Systems deviations.
• Equipment Maintenance and Instrument Calibration management for all manufacturing systems to comply with current health care regulations.

Akorn Inc.

Vaccines in Decatur, Illinois

June 2017 to Mar 2018

• Equipment and Instrument Calibration Management, Computer Systems Gap Assessment, Remediation and Validation with focus on CSV Data Security and Integrity.

• Quality Systems-Deviations/Investigations on Process equipment and Computer Systems

Emcure Pharmaceuticals

Solid Dosage and Cancer Drugs Pharmaceutical in Pune, India

Mar 2016 to Mar 2017

• Computer Systems Gap Assessment, Remediation and Validation with focus on Instrument Calibration, CSV Data Security and Integrity.

• Audit and Gap assessment of Calibration and Computer systems for HVAC, Critical Utilities (Purified Water and WFI), Oil Free Compressed Air, Nitrogen, Filling and Sealing, Tunnel Sterilizers, Isolators, Packaging Equipment.

Mylan Inc.

Solid Dosage and Cancer Drugs Pharmaceutical in Bangalore, India

June 2015 to Mar 2016

• Auditor-reviewed Facilities, Equipment, Calibration, Critical Utilities Computer Systems Validation, QA compliance related documents and Gap Impact Assessments. 

• Planned shutdown. Activities with Smoke Flow Studies and Aseptic Techniques, Environmental Monitoring, Media Fill, Sealing, Capping, Inspection and Packaging Operations

McNeil Inc. - Lancaster, Pennsylvania

October 2014 to Dec. 2014

• Electronic Batch Record System MES of Solid dosage products
• Validation of Computerized Process Equipment (Granulation, Drying, Compression, Coating, and Packaging) with PLC’s, DCS and BMS.

• Gap Assessment and Remediation of the company Equipment and Instrument Calibration program.

Merck-Serrono -Barcelona, Spain

Dec. 2013 to Oct. 2014

QA Engineer for Quality Assurance Department and Compliance Department. 

• Generated and executed Facilities and Manufacturing Equipment Validation documents URS, FRS, FAT, SAT,IQ, OQ, PQ for process vessels and transfer lines including HVAC, BMS, BAS, HWI and CWFI Generation and Distribution System, Granulation, Compression, Coating and Packaging of solid dose products.

Novartis-Sienna, Italy May 2013 to Dec. 2013

• Generation and Execution of URS, FRS, FAT, SAT,IQ, OQ, PQ  process equipment and facility related utilities (HVAC, BMS, BAS). 

McNeil- Puerto Rico

Jan. 2011 to May 2013

• Installation of the first Electronic Batch Record System (MES), Computerized Equipment Validation of Critical utilities, Granulation, Solutions Preparation, Compression and Packaging of solid dose products.

Hospira Pharmaceuticals

Rocky Mount, North Carolina Feb 2010 to Dec. 2010

• Batch Record Reviews and Investigations on manufacturing related deviations on Equipment and Instrument Calibration, and Computer Systems.
• Validation of Critical utilities, Solutions Preparation, Fill and Finish of Sterile products (vaccines and IV solutions).

Amylin Pharmaceuticals-Sharonville, Ohio

Quality/Validation Engineering Consultant

February to April 2010

• Generated and executed IQ, OQ, PQ cleaning validation for process vessels and transfer lines including HWI and CWFI Generation and Distribution System.  

Leiner Health Products-Carson, California

Validation/Engineering Consultant

November 2007 to August 2008

• Decommissioning of an old plant in South Carolina (Fill, Finish, Packaging equipment with stand-alone Allen Bradley PLC’s, HMI’s), cataloguing or inventory control of shipment. 
• Led and managed engineering/construction reinstallation, equipment and instrument calibration commissioning and validation projects on the receiving site (Carson, Calif).

• Performed Gap Analyses on the Packaging Equipment, Utility Systems, Calibration of equipment and instruments, and made recommendation for CAPA to the Validation and Compliance Department.

Baxter-Thousand Oaks, California

Senior Contract Project Engineer

January 2007 to July 2007

• Engineering and Calibration support for the Suite a Refurbishment (Media and Buffer Preparation, Culture and Purification Areas), and Compressed Air system.

The Quantic Group, Ltd. – Livingston, NJ

Consultant/Auditor: Quality systems and Validation

April 2002 to July 2006

Schering Plough, Puerto Rico

Wyeth Inc.in Pearl River, New Jersey 

McNeil Inc. Puerto Rico

Cardinal Pharmaceuticals Inc, San Diego, California

• Wrote and Executed Validation Documents (IQ, OQ, PD, PQ), Calibration and CSV’s for Critical Utilities (WFI Generation, Storage and Distribution System, Clean Steam, BMS System, Production Equipment (Buffer and Media Preparation including Storage and Distribution, Fermenters, BioReactors, Ultrafiltration, Purification, Lyophilization, Fill and Finish, Packaging Machineries).
• Validation of steam sterilizers (Finn Aqua/Steris, Castle, and Kuhlman).
• Cycle improvements/load development (minimum-maximum loads for wet and dry goods loads.)
• Managed instrument calibration system for the equipment

Bayer Corporation-Berkeley, California

Project /Validation Engineer/Manager for Plasma/Recombinant DNA Production Facilities

March 1978 to Dec. 2001

Lead Project Engineer for a new recombinant DNA production facility.

• Design the processes, size, and specify equipment and computer systems (PLC’s, HMI’s, SCADAS, DCS) obtain and review bids for equipment purchased and provided functional description for the processes.  Interacted with other engineering and architectural disciplines to coordinate construction activities.  

INTERNATIONAL SOCIETY OF PHARMACEUTICAL ENGINEERS (ISPE) 

AMERICAN SOCIETY OF CHEMICAL ENGINEERS (AICHE)

PARENTERAL DRUG ASSOCIATION (PDA) 

SOCIETY OF PACKAGING AND MATERIAL HANDLING ENGINEERS (SPHE)