MedImmune

Multiple projects at four individual sites (Manufacturing, Pilot Plant, Warehouse, Fill Finish Facility). Function as Automation qualification support with signature authority for BMS and PCS installations and upgrades. Qualified multiple software upgrades to Siedenader vision inspection machine. Automation qualification for new high speed filler used to support of H1N1 vaccine production. Installed, integrated, qualified and provide continuing support for automated environmental monitoring software for class 100 filling suites. cGMP equipment qualified includes cGMP Utilities including WFI, Compressed Air, Clean Steam and RODI. Process equipment including bioreactors, chromatography, transfer panels and filtration skids. Controlled temperature units qualified include incubators, refrigerators, freezers, -80C freezers and warehouses. Thermal mapping is accomplished with wireless data accumulators instead of strung thermocouples.

SPI Pharma

ECSquared acts as the validation partner for SPI. All new and existing equipment / systems are validated by ECSquared. Wrote and executed IOQs for legacy vessels and production equipment for this bulk manufacturer. Validated production equipment including a homogenizer, filling machine and the control system associated with equipment and vessels. Micro lab equipment included CTU’s bio-analyzer, Vitek, RO water system and washer. Generated the initial qualification package for the client’s new portable cleanroom equipment.

Pfizer

Managed, wrote, executed and reported CIP and Cleaning OQ and PQ for this multi-product facility. Reviewed and signed off on cleaning batch records. Managed the schedule, reporting and tracking for the qualification of the product change-over for each new campaign, new equipment being introduced to the facility and consulted on contamination investigations.
Validated the bioreactors, media tanks, buffer tanks, multi-filtration skids, centrifuges, column packing skids and chromatography columns. These validations included CSV assessments, CSV qualifications, equipment walk-downs, review of open change controls and abbreviated cleaning studies to ensure that the cleaning procedure remains effective. Validated utility systems which included the carbon dioxide system, nitrogen distribution system and HVAC system. Performed cleaning studies to verify that all process equipment is cleaned during product changeovers.

Emergent BioSolutions

Provided validation leadership and qualification of both of this client’s production streams. The qualifications included all controlled-temperature units (coldrooms, freezers, incubators and refrigerators), diaphragm pumps and autoclave dry and liquid loads. Performed steam quality testing of all systems using clean steam to verify that the equipment was compliant with European standards.

Johnson & Johnson

Project Management and Lead Validation Consultation for the qualification of two new GxP Pilot Plants for this client. Management of the start-up of the pilot plants and the generation and execution of guidance documents, batch records, SOPs, Computer System Validation, VMP, IQ, OQ and PQ’s for all GxP utilities, process equipment and support equipment. Worked with Quality to write, review and align new processes and procedures to come in line with GAMP5 and GxP. Validation efforts included URS, FRS, DDS, SDS, IQ/ UAT, Trace Matrix, Risk Assessment and CSV Training as required by J&J Corporate standards. Utilities included Purified Water, HVAC, Clean Steam, Clean Compressed Air and Dust Collection. Process equipment included Liquid Filler, High Shear Mixers, Glatt powder coaters, tablet press and a tablet coater.

Akorn

Start-up and qualification of this sites new BMS and HVAC for a Sterile Fill Manufacturing Facility. ECSquared was assigned to oversee a team of mechanical engineers, software engineers, CSV specialists and validation specialists to bring the system on-line, perform start-up and qualification and validation. Control and data storage validated to ensure CSV, GAMP5 and Part 11 compliance.

Auxillium

Validation for start up of the biotech’s new production train. Qualified cGMP utilities, walk in cold rooms, process vessels, process equipment cGMP washers and control systems. Duties included writing justifications and protocols for equipment and executing qualifications with follow-up reporting.

Centocor

Qualify equipment at Building 4 manufacturing facility for start-up and later at the R&D Pilot Plant facility in support of on-going development processes. All aspects of start-up qualifications from SCADA and BMS to process equipment including bioreactors and down-stream purification and cGMP Utilities for WFI, RODI and clean steam.

Novartis Pharmaceuticals

Updated client URSs (User Requirement Specifications), FRA (Functional Risk Assessment) and Trace Matrix to begin the validation of their new and relocated utilities. Generated the installation, operation and performance qualification protocols for the watering system in their new vivarium.

Wyeth

Validation at a vaccines facility included developing and executing a site-wide program for clean steam quality testing. These tests included testing for non-condensable gases, superheat and dryness per HTM-2010 (British Health Technical Memorandum) and EN-285 (European Regulatory Standard.) Validation duties also included developing and executing an environmental monitoring program for the client’s new media facility, as well as developing and executing cleaning validation programs for the same facility.
Developed validation protocols for environmental monitoring in a multi-class media facility. Validation included air and surface testing for viable and non-viable microbes and particulates.

Costco Wholesale

Installed and preform long term temperature and humidity wireless monitoring system. This system monitors over 50 points inside multiple temperate range rooms with alarm and notification capability. This system is fully wireless and was installed with no interruption of normal operation.

Neose

Function as the validation department for the company with signature authority. Responsibilities include maintaining qualification status for all cGMP equipment, instruments and utilities. Qualification of laboratory instruments, controlled temperature units (CTU’s) and utilities for this early development biotech company.

TyRX

Performe “real-time” wireless thermal map of an oven used for a time and temperature critical process with no thermocouple intrusions to alter data.

MacroGenics

Given signature authority for start-up qualification activities for this biotech company. Reviewed and approved qualifications for all portions within the cGMP envelope.