PROJECTS
2008 – 2010
Bulk Antibiotic Facility Renovation
- Conceptual design and Basis of Design for component and equipment preparation area
- Development of equipment layouts, P&IDs, PFDs, equipment list and equipment datasheets.
New Bulk Vaccine Facility Expansion
- Detailed design through SAT of a two 16 Tank Buffer Preparation and Hold suites.
- Detailed design through construction of a Bulk Sterile Filling Skid.
- Start-up, commissioning and troubleshooting of Buffer prep/hold, Microfiltration, Chromatography and Ultrafiltration skids.
- Development of through-put data and cost estimation for Sterile Supply Area washers, autoclaves and dry heat ovens.
Bulk Vaccine Facility Process Equipment Retrofit
- Detailed Design support for existing and new equipment (Datasheets, Specifications, FAT, SAT, review and approval of 3D Models)
- Management of vendors (off site construction and on-site install) and management and execution FAT and SAT of process skids
- Building-wide diaphragm valve replacement project
Bulk Vaccine Fill Facility (EU)
- Detailed design through SAT for custom Process/Sonication/Filtration skid
Phase 3 Vaccine Project
- Conceptual design through support validation for a large-scale yeast fermentation and purification process (PFDs, P&IDs, Data Sheets, Design Summary and HAZOPs).
Bulk Vaccine Facilities – Process & Automation & Remediation
· Conversion from existing Provox® platform to DeltaV® platform (control loops, recipes, and
phases).
equivalencies, data archiving and process quality).
· Process Validation, Stability Protocols and Manufacturing Document r-designs for Recovery, Purification and Media/Buffer steps).
· Design and modification of process skids to comply with sterile/sanitary requirements.
· Preparation and execution of FATs, SATs and IOPQ for improved manufacturing processes.
· Troubleshooting, investigation of deviations and resolution of manufacturing problems
· Design and shakedown of CIP and SIP routs for the process skids.
· Operating and troubleshooting software and hardware of DeltaV, Unicorn, and AB-PLC systems.
· Deviation Management / Investigating Atypical Process Events and Atypical
· Product Impact Assessments for Sterile Vaccine Products
· Continuous Process Improvement & Development of Corrective & Preventive
· Automation for a 51,000 square-foot GMP mammalian cell facility (DeltaV®, 10 equipment skids, and Vial Fill Line.
Biologics R&D Pilot Plant Upgrade
· FAT, start-up and commissioning and qualification of Buffer Distribution skid
· Determination of sterile boundaries for fermentation equipment.
Biologics Contract Manufacturer
· Detailed engineering for modification of bioreactor vent systems.
2006 – 2008
Biologics and Pharmaceutical R&D Facility
· Development of Validation Master Plan
· Investigation and troubleshooting of OOS reports
· Start-up/Troubleshooting and Validation of process equipment (bioreactor, fermentor, CIP skid, high purity water system, clean steam system and lab equipment)
Bulk Vaccine Facility Upgrades
· Submittals review and approval (P&IDs, General Arrangements, Datasheets, and Specifications) of a Sterile Adjuvant System.
· FATs, Installation, Start-up, Troubleshooting and Commissioning
· Commissioning Master Plan, Test Plans, execution and validation support
· Remediation of a buffer prep and buffer hold equipment (equipment P&ID’s recommended new CIP/SIP flowpaths.
Biologics R&D Pilot Lab
· Development of CIP, SIP, and Product Transfer flow paths and valve sequencing
· Management of Devicenet system, , Teledata/Ethernet, Electrical/UPS, PCS implementation (reporting, security, HMI installation/continuity, flow path/circuit implementation, integration with vendors systems integration)
· Commissioning of autoclaves and parts washers.
New Bulk Vaccine Facility Expansion
· Design documentation, model development, management of vendor install of equipment, FAT and SAT for Buffer Prep/Hold Skids, Micro/Ultra-filtration and Chromatography.
· Development of through put data and cost estimates for Sterile Supplies equipment (washers, autoclaves and dry heat ovens).
· Model reviews
· Operating and troubleshooting software and hardware of DeltaV, Unicorn, and AB-PLC system.
Biologics Bulk Contract Manufacturer
· Equipment/facility solutions for process equipment Change Control, equipment electrical modifications, PM scheduling, utility modifications, facility shutdowns, and other associated tasks.
Biologics Bulk Filling Contractor
· Process Development for New Sterile Blow Fill Seal Products
· Design and Execution of Feasibility & Engineering studies and development of Batch Records for New Processes
· Development of Sterility Assurance Validation Master Plans authoring of summary reports
· Deviation Investigation & Authoring Deviation Reports
2002 – 2006
Bulk Vaccine Facilities – Process Sciences
• Improvement of Media Challenge Process and vaccine production processes
• Performance of lab scale studies (raw materials approvals from new vendor, piping materials compatibility study and valve leak tests.
Process Engineering Support Services
• Consulting services for Pressure Relief design and use of pressure vessels and equipment.
• Evaluated process safety by assuring structural integrity of the components, regulation of
Bulk Cell Culture Drug Facility (EU & Peurto Rico)
- Provide consulting process engineering expertise to on Cell Culture Media process and WFI System project
Biologics R&D Pilot Plant A, B and C
- Design, BOD development, start-up and commissioning
- Specification and quotation review for all equipment, design review of all equipment and utilities, project/personnel scheduling, small equipment procurement, FAT coordination, commissioning test plan development, and execution.
- Execution of FAT for automated filtration skids, process vessels, autoclaves and laminar flow hoods.
- Start-up, troubleshooting, commissioning and validation support for bioreactors, buffer storage containers, autoclaves, parts washer, media/buffer skids, custom blast freezer, disposable bioreactors, waste water reclamation system, USP water system, clean steam generator and distribution system.
- Development and execution of start-up and commissioning and load patterns for parts washer and autoclave.
- Reviewed automation and controls designs (URS/FRS/DDS)
- Engineering support for construction punch-list, equipment changes, PFD reviews, equipment layouts proofs, SOPs, PM plans and P&ID and GA redlines for as-builts.
Bulk Biologics Facility A
Design support for all process equipment and process utilities including 2 x 12,500L bioreactors and bulk shipping containers.
- Start-up, troubleshooting and commissioning of production scale bioreactors, CIP,
MF/UF systems and LC systems and ultra filtration systems.
- Troubleshooting automation integration issues
- Commissioning and validation support for WFI, RO, glycol, biowaste, waste neutralization, CIP systems, chillers, re-heat coils, boilers, plant steam, clean steam systems and Siemens BMS.
GMP Fermentation Plant
· Equipment/facility solutions for process equipment change control, equipment electrical modifications, PM scheduling, utility modifications, facility shutdowns and associated tasks.
- Created system to control the process equipment spare parts inventory.
- Provided real-time remediation for equipment breakdowns during GMP processing.
· FAT, start-up, commissioning and troubleshooting and validation support for custom automated chromatography skid, MF/UF Skid, large-scale chromatography columns, column packing skid and continuous centrifuge.
Bulk Biologics Facility B
· Development of URS/FRS/DDS for automated process chromatography skids, packing skid, and MF/UF skids
· Design reviews (BOD, equipment list, layouts, P&IDs, PFDs and GAs) for chromatography systems, MF/UF systems and portable vessels
· Design review for multiple projects with prototype bioreactor, product hold vessels, depth filtration skid, support utilities, and facility layout.
· HAZOP review for both upstream and downstream equipment
· Development of Sterilization Out of Place (SOP) Cycle for alternating Tangential Flow Filters and depth filter housings
· Design review, FAT, commissioning and start-up support for upstream purification equipment (product hold vessels, CIP skid, HWFI skid, temperature control modules and utility expansion of clean steam, clean air, plant steam, and chilled water).
· FAT, start-up, commissioning, troubleshooting and validation support for GMP autoclave.
Bulk Cell Culture Drug Facility (EU)
- Lead engineering function from the conceptual design phase through detailed design of a 100MM cell culture manufacturing facility expansion and utilities upgrade.
· Design review and design development (PFDs, P&IDs and URSes) for all new process equipment skids (e.g. bioreactors, chromatography systems, UF/DF system and CIP skid)
Contract Fermentation and Cell Culture Manufacturer
· Specification and procurement of fermentor and cell culture equipment including re-folding tank and large-scale disc-stack centrifuge.
· Manufacturing process transfer for commercial production of bulk drug product.
· Design and implementation of fermentation feed and control strategy at large-scale including characterization of kLa, tip speeds, mixing times and response times.
· Development of process parameters for recovery steps (liquid-liquid extraction, refolding, liquid – liquid separation, filtration and clarification via TFF/centrifugation)
GMP Oligonucleotide Facility
· Automation, documentation and validation for of DeltaV controls
· Vendor source code and IT compliance audits.
Prior to 2002
Biologics R&D Pilot Plant A
- FAT, start-up, CIP/SIP development and validation support for multiple bioreactors, fermentors, chromatography skids, cell homogenizer, process vessels, CIP systems, TFF skids, depth filters, autoclaves and dry heat ovens.
- Start-up and management of lab equipment (e.g. laminar flow hood, balances, stir plates, pumps, centrifuges, water baths, sterile tubing welders, spectrophotometers, refractometers, and filter integrity testers).
- Development of SOPs (operation, CIP/SIP) and PM plans for all process equipment.
- Preparation of VMP and execution of IOPQ protocols for software, utilities, and processing equipment.
- Construction completion oversight for processing suites
- Preparation and execution of batch process documentation for engineering and cGMP batches of fermentation, cell culture and purification lots,
- Execution of mixing experiments in bioreactors, PID loop tuning for DO and pH control.
- Modification of skid automation under change control
Biologics R&D Pilot Plant B
- Pilot Plant bioreactor engineering studies (CIP/SIP/Operability and aseptic transfers)
Bulk Cell Culture Drug Facility
· Laboratory autoclave engineering study (suitability for validation) and valve and filter housing SIP studies
GMP Fermentation Plant
- Troubleshooting and commissioning for production scale fermentor and associated process equipment.
Bulk Vaccine (Fermentation) Drug Facility
· Vaccine manufacturing facility start-up, IQ/OQ and CIP/SIP cycle development and validation.
· Manufacturing process shake-down, batch record development and clinical manufacturing support.
· PLA preparation, operator training, SOP development, change control,
Biologics Start-Up Company
- Detailed P&ID reviews for sterile processing equipment, CIP and SIP
- Review and approval of Fermentation and Purification PFDs and Pilot plant production metrics
· Screening, due diligence and selection of a contract bio-manufacturing facility for lead drug candidate (Phase i)
Barrier Isolation Vial Filling Line
- Computer system validation for a locally controlled Environment (LCE).
- Development of test protocols for SCADA and PLC
- SOP development and field testing and troubleshooting
Bulk Biologics Facility A
· Development and execution of FAT and IOQ for 8,500L buffer tanks, Chromatography skids, MF/UF systems, and CIP skids.
Biological Sample Storage and Testing Facility
· Development and execution of validation (IOPQ) for controlled temperature units, terminal HEPA Filters and Biosafety cabinets.
Biologics R&D Pilot Plant C
· Development of PM procedures for all process equipment (incubators, bioreactors, MF/UF skids, parts washer, autoclave, CIP skid, lab equipment and process support equipment.
Biochemical R&D Pilot Plant
· Modification and maintenance of fermentor code for operation, CIP and SIP
· Support for Migration of a Provox DCS to a DeltaV system
Biologics Start-Up Company
· Production, troubleshooting and engineering support for MAb production with CHO, Hybridoma and E. coli cultures.
· Scaled-up from bench to 200L bioreactors and harvest via TFF.
· Technology transfer to pilot plant and manufacturing facility.
Bulk Biologics Facility A
· Design, and implementation of modifications to a chilled water system
· Engineering and installation of a Purified Water System
Animal Growth Hormone Facility
· FAT, SAT, commissioning and testing of Provox system for fermentation, isolation, purification, lyophilization, formulation, syringe filling and packaging
· Developed of DDS, SOPs and Change Control Procedure
· Supported AspenTech data historian and electronic batch report system
· Development and execution of validation protocols for automation and process equipment
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