Engineering Manager

Objective: To add value as a result of my experience in the biologics and biopharmaceutical large scale manufacturing arena, supported by my engineering management/leadership skills and experience operating in the United States, United Kingdom and Europe.

Summary of Experience:

Extensive design, construction, commissioning and validation experience. The main thrust and experience has been within the biotechnical/biologics, pharmaceutical and fine chemical industries.

Ultra-Pure Systems Inc., North America July 2013 – Present

Director of Strategic Project Development

Responsibilities:

Develop the capabilities of a new business operation including, Engineering Design, Fabrication, Construction and Start-up & Commissioning, located in the Research Triangle Park of Raleigh, North Carolina.

Grow the work force of engineers and designers, instrumentation & controls, hygienic high purity fitting and welding with the skill sets to develop the production of biopharmaceutical Process Flow Diagrams (PFD’s) into construction grade Piping & Instrumentation Diagrams (P&ID’s).

This facility has the capability to design, fabricate, test and validate hygienic modules and unit operation skids. The work force is capable of designing, fabricating and installing high purity and utility piping, in situation, for both the biologics and pharmaceutical industries.

M+W Group USA June 2012 – June 2013

Operations Director: Life Science

Responsibilities:

Develop and operate a new business office platform, located near the Research Triangle Park (RTP), Raleigh, NC.

Hire and develop all necessary personnel to support the engineering design, construction, commissioning and qualification of large scale biologics manufacturing including sterile formulation fill & finish facilities, packaging and distribution for the biopharmaceutical industry.

Logistical area coverage is the US. Eastern seaboard including Puerto Rico.

Grifols Biotherapeutics (formerly Talecris) Jan. 2010 – June 2012

Project Director North Fractionation Facility

Blood Fractionation Manufacturing Site Campus

Clayton, NC 27527

Total Installed Costs: $430 MM

Responsibilities:

Manage project through qualification and report results against established parameters.

Develop project team, and direct the interface between Talecris management/operations and external companies.

Engineering design input/oversight.

Accountable for all aspects of engineering and process design, process and clean utilities.

Initial engineering/process wet runs with plasma, to support OQ and PQ.

Early interface with the commissioning and qualification engineers.

The capital project team consisted of process, mechanical, utility, architectural, instrumentation and automation engineers. As well, dedicated support from the existing site was integrated into the team - maintenance, manufacturing, operations, QA/QC, technical support and validation.

Deliverables included:

Process and clean utility equipment factory acceptance test approval (FAT).

Production of User Requirement Statements (URS) and Functional Requirement Specifications (FRS).

Approval of shop and IFC drawings.

Unit operational Super Skids and commensurate commissioning.

Deliver completed facility, commissioned through IQ/OQ with continuing PQ support.

The project consisted of the following phases:

Conceptual/Preliminary Design:

Engineering & Detail Design:

Construction and Commissioning.

Start-Up through IQ/OQ/ with PQ support.

The Precipitation Unit Operation super skid comprised of sixteen vessels located within eight modules. Each module was prefabricated in sections off site and final assembled on site.

Instruments and control valves were ‘loop’ checked using the (Delta V) automation software code within the assembly shop.

The Centrifuge Control Modules (16 total) were designed, fabricated, assembled in a similar manner.

The resulting effect of this approach led to the assurance of quality, cost control and severe schedule compression.

It should also be noted that the final assembly on site, enabled each super skid to be pre-constructed to an optimum size, not being limited by transportation height and weight constraints.

Fractionation Manufacturing Facility:

160,000 sq. ft. Facility.

Design capacity 6 MM liters per year of Plasma Fractionate.

Operation at process utilization at 85%.

Facility to operate 7 days wk./24 hrs.

Facility designed to be expanded.

Upstream manufacturing within closed systems.

Regulatory – FDA, Canada and European Union.

Bristol Myers Squib 2007-2009

Project Director Biologics

Large Scale Cell Culture Manufacturing Site Campus, Devens, MA

Total Installed Cost: Circa $750MM

Responsibilities:

Manage the project through qualification.

Develop the project team and direct the interfaces between BMS management, construction and operations.

Accountable for all aspects of engineering and process design, utilities, and modular skids.

Deliver completed facility commissioned through IQ/OQ with continued PQ support.

The project team consisted of process, mechanical, utility, architectural, instrumentation and automation designers and engineers, with dedicated support from maintenance, manufacturing, QA/QC and tech. operations

Deliverables included:

Conceptual Design:

Manufacturing and Utility facility PFD and UFD production.

Detail Design:

Develop concept design documents through P&ID and 3D Model design.

Construction:

Interface and coordination between the Construction Management firm, BMS Site Operations and BMS Corporate.

Start-Up & Commissioning:

Process and clean utility factory acceptance tests (FAT) approval.

Realization of system by system start-up to support full scale engineering runs - handing off at PQ to Operations. The ASME E2500 system was adopted.

Engineering Design:

All Buffer and Media preparation unit operations were built out of place as pre-engineered super skids.

Campus: 90-Acre site/450 Employees/ Phase 1.

One Large Scale Cell Culture Manufacturing Facility (BL1LS)

190k sq. feet footprint – three levels.

335 days/year - 80% Utilization.

6 – 20KL Bioreactors / 3 Seed Trains.

4 – 2 Meter Column Purification Suite.

One Central Utility Building – 43K sq. feet footprint – High Bay/ two levels.

One Laboratory/Office/Cafeteria Facility.

One GMP Warehouse:

One Chemical Storage Building: One Parking Structure.

One waste water treatment plant.

Amgen Manufacturing Ltd. 1997 - 2007

Assoc. Director, Offshore Engineering

OPUS: Biologics Manufacturing Site Complex, Juncos, Puerto Rico

Total installed Cost: circa $1.25B

Responsibilities: All aspects of engineering and process design, unit operational modular (Super Skids) design, construction, start-up & commissioning.

Conceptual Design: Initial conceptual logistical site layouts and integrated facility locations.

Detail Design: Development of conceptual design through P&ID and 3D Model design completion of IFC documentation.

All process unit operations were designed and built on site as ‘Super Skids’.

Construction: Construction Management contractual negotiations. Engineering interpretation, subcontractor monitoring, RFI and SI coordination and final MC/Turn-Over punch list coordination.

Start-Up & Commissioning: Full engineering involvement and responsibility for the realization of system by system start-up.

The capital project team consisted of process, mechanical, utility, architectural, instrumentation and automation engineers. In addition, dedicated support from the existing site was integrated into the team, maintenance, manufacturing, operations, QA/QC, technical support and validation.

Deliverables included:

Engineering design input/oversight.

process and clean utility equipment factory acceptance test approval (FAT).

User Requirement Statements (URS) and Functional Requirement Specifications (FRS).

Approval of all equipment fabrication and shop drawings.

Initial engineering/process wet runs to support final commissioning, start-up through IQ, OQ and PQ support.

Two large scale Biopharmaceutical manufacturing facilities.

-Large scale Microbial manufacturing (LSMC) – 2,500-liter scale fermentation.

-Large scale Cell Culture manufacturing (LSCC) – 5 x 15,000-liter scale bio reaction.

-Clean Utilities separately dedicated inside each manufacturing facility.

One Central Utilities Plant with all related off-sites.

Retro fit of one large scale Formulation/Fill Facility.

One large scale Process Development Laboratory.

One Large scale Quality Assurance Laboratory.

One Waste Water Treatment Facility

One GMP Finished Goods Self Contained Warehouse.

One GMP Raw Materials and Finished Goods Warehouse with GMP connecting spine to all manufacturing facilities.

Administration/Cafeteria/Gym complex and support infrastructure.

Manager Plant Projects:

Responsible for all clean utility and process related new, expanded and retrofitted capital projects to the corporate manufacturing campus located in Thousand Oaks, California.

Project Manager: Corporate Engineering.

Lake Centre, CO: Large Scale Bulk Manufacturing Expansion (LCX)

Cell Culture Bio reaction and Purification.

Longmont, CO: CHO Large Scale Cell Culture (LSCC) Manufacturing Facility

Fully automated roller bottle technology.

Longmont, CO: Large Scale Multi Product Manufacturing Facility (AMPM conceptual study)

Puerto Rico: Fill & Finish Facility Expansion (PRFFX)

One syringe line, one vial line and 2 packaging lines. Plus, all clean and plant utilities.

Fluor Daniel- Center for Biopharmaceutical Design, Greenville, SC 1979 to 1997

Fluor Daniel Experience:

Multiple projects as detailed in the following:

Engineering Quality Control Manager for Fluor Daniel: Jurisdiction covered global Bio/Pharma projects.

Site Master planning and facility conceptual studies Facility Integration. Room Classifications, Air Flow, People/Material/Waste flow patterns.

Regulatory Authority presentations of proposed Biotech manufacturing facilities Ensuring cGMP compliance through engineering interpretation of regulatory guidelines.

Ensuring correct interpretation of design intent during construction Coordinating with construction management to maintain schedule and control budget.

Project Manager, Bio/Pharma projects for Fluor Daniel:

Coordinating, Local authorities, Engineering, and Manufacturing during contract negotiations. Coordinating Manufacturing, Engineering, Procurement, Construction, Validation and Start-Up. Responsible for schedule and budget.

Construction Manager, Bio/Pharma projects for Fluor Daniel: Responsible for all aspects of design/construction co-ordination. Co-coordinating Validation with Start-Up. Transitioning from Engineering Mechanical Lead during design phase into construction phase.

Engineering Mechanical Manager, Bio/Pharma projects for Fluor Daniel: Responsible for all aspects of hygienic and plant piping design. cGMP interpretation and compliance. Cost Control/Scheduling, and Installation.

Corning BioPro Inc., Research Triangle Park, North Carolina 1996 – 1997

Engineering Quality Control Manager

Project Phases were:

Construction; Engineering Project Management; Validation.

Responsible for the engineering quality, cGMPs and regulatory affairs for the civil, structural, piping, HVAC, architectural, instrumentation\controls and equipment procurement disciplines.

Design and construct a CBHR regulated and approved multiproduct contract manufacturing facility.

The manufacturing area is split into two separate processing trains:

Microbial, a common growth train and two separate recovery rooms.

Cell Culture, multiple growth trains and two separate harvest rooms.

The purification area is common, comprising two separate purification rooms linked by a common bulk fill room. All clean utilities are required.

Lederle Praxis Biologics, Sanford, North Carolina 1995 – 1996

Engineering Quality Control Manager - Site Expansion Project

Project Phases were:

Engineering; Procurement; Project & Construction Management; Validation.

Responsible for the engineering quality, cGMPs and regulatory affairs for the civil, structural, piping, HVAC, architectural, instrumentation\controls and equipment procurement disciplines.

This project added the capabilities to perform conjunction for a 9 valent Pneumo Conjugate Pediatric vaccine to the existing LPB facility. Process and support functions include fermentation, media preparation, purification, buffer preparation and bulk fill. All clean utilities were required.

Eli Lilly, Inc., Indianapolis, Indiana 1994 - 1995

Engineering Quality Control Manager - Cell Culture Facility

Project Phases were:

Engineering; Procurement; Project & Construction Management; Validation.

Responsible for the engineering quality, cGMPs and regulatory affairs for the civil, structural, piping, HVAC, architectural, instrumentation\controls and equipment procurement disciplines.

Design and install in an existing building, a CBER regulated and approved manufacturing facility for the production of a generic cell culture derived therapeutic.

The Eli Lilly Institutional Biosafety Committee selected this level of physical containment for large-scale production of the recombinant organism as Biosafety Level 1 - Large Scale (BL1-LS). The process includes bio recreation, harvest, purification, media and buffer preparation, and bulk fill. All clean utilities are required.

Chiron, Inc., Canovanas, Puerto Rico 1992 -1993

Engineering Quality Control Manager:

Chiron Betaseron Project (beta interferon).

Project Phases were:

Engineering; Procurement; Project & Construction Management

Project Scope:

Procurement, hygienic design and cGMP compliance for this production scale facility where frozen fermented broth is thawed, purified, filled and finished.

The product is Beta Interferon, a therapeutic protein used in the treatment of muscular sclerosis.

This is an existing biotech facility retrofitted to contain buffer preparation recovery, purification, bulk fill and final fill and finish. All clean utilities are required.

Sophisticated clean-in-place (CIP) capabilities are designed to be integral with the process systems.

Synergen Inc., Boulder, Colorado 1990 - 1992

Engineering Quality Control Manager

Lake Centre Facility: Interleukin 2-Ra

Engineering, Procurement and Project Management.

Project Scope:

Equipment procurement, civil, structural, piping, HVAC, architectural, instrumentation, engineering hygienic design and cGMP compliance.

E-Coli homogenization for the extraction and purification of recombinant human Interluekin-2-Ra.

Fermentation (contained), cell culture, recovery and purification to sterile (non-validated) bulk.

WFI generation and circulation in a hot loop and RO generation and circulation in an ambient loop.

CIP and sterile-in-place (SIP) capabilities are designed to be integral with the process systems.

All cGMP requirements (FDA, DHSS and EC) including clean ability, sterile control, bio containment and personnel flow.

Hoffman-La Roche, Nutley, New Jersey 1989 – 1990

Engineering Project Manager

IL-2 (Interluekin-2)

Engineering and Project Management

Project Manager responsible for all disciplines of engineering and hygienic design and compliance with cGMPs for this production facility where E-Coli cells are homogenized for the extraction and purification of recombinant human Interleukin-2. Total responsibilities included detailed design, construction, validation and start-up. Maintained Schedule, Budget and Contract.

Ortho Biologics, Inc., Manati, Puerto Rico 1988 - 1989

Engineering Quality Control Manager

Large Scale EPO (Erythropoietin) Manufacturing.

Engineering, Procurement and Project Management

Project Engineer and Design Quality Coordinator. Responsible for structural, piping and instrumentation engineering design, equipment procurement and hygienic design\cGMP compliance.

Project Scope:

Scale-up production facility including fermentation, media and buffer preparation, harvest, roller bottle filling and chromatography downstream processing.

Fermentation is designed to NIH biosafety Level 1, cold rooms to FDA air Class 10,000 and product transfer to Class 100 (laminar flow). The facility includes extensive dedicated CIP and SIP capabilities.

Amgen, Inc., Thousand Oaks, California 1987 - 1988

Engineering Mechanical Manager: Construction Manager

EPO Manufacturing (Erythropoietin)

Engineering, Procurement, Project Management and Construction

Mechanical Engineering Lead responsible for the design integration of all disciplines. And the application of all applicable cGMPs. The project was a scale up biotech production facility including sterile and hygienic utilities and process. Processes are fermentation, media and buffer preparation, roller bottle filling and harvest, purification and final fill. Clean utilities are WFI, clean steam, CIP solutions and waste neutralization.

Biochemie, Kundl, Austria 1986 - 1987

Engineering Quality Control Manager: Construction Manager

Engineering, Procurement, and Construction Management

Engineering coordinator responsible for the design integration of all disciplines, verification and approval of all contractors’ construction documents and correct application of relevant FDA and EC cGMPs. The project is a scale up biotech production facility including sterile and hygienic utilities and process systems. Process include: media and buffer preparation, purification and final fill. Clean utilities are WFI, clean steam, deionized water, CIP solutions and waste neutralization.

Karl Thomae GmbH, Biberach, Germany 1985 – 1986

Hygienic Engineering Design Consultant

Engineering and Construction Management

Consultant in all design matters pertaining to sterility, hygienic design and relevant cGMPs. Consulting and coordinating with European design and construction contractors. The project was designed and built under license from Genentech, South San Francisco to manufacture tPa.

Genentech, Inc., South San Francisco, CA 1984 - 1985

Engineering Mechanical Manager

Large Scale Manufacturing: tPa.

Engineering, Procurement, and Construction Management

Responsible for all piping process, clean utility and waste systems, vessel and limited equipment design, plot layout and arrangement. Production of construction and fabrication drawings. Construction interface.

Clean utilities are WFI, clean steam, deionized water.

Eli Lilly Inc., Mayaguez & Carolina Puerto Rico 1983 - 1984

Piping Design Supervisor - Synthetic Penicillin

Engineering, Procurement, Construction and Construction

Piping design supervisor responsible for all piping processes, utility and waste water systems, vessel and equipment design, plot and equipment layout and arrangement, on-site construction interface, production of construction and fabrication documents. The project covered two sister pharmaceutical facilities which include hygienic and sanitize able systems. Clean utilities are; deionized water, clean steam and waste deactivation.

Corn Products, Inc., Stockton, California 1979 – 1982

Piping Design Supervisor - Fructose\Dextrose

Engineering, Procurement, and Construction Management

Piping design supervisor responsible for all piping processes, utility and waste water systems, vessel design, plot and equipment layout and arrangement. Production of construction and fabrication documents. The project contained two sister corn wet milling facilities to produce fructose and dextrose. Processes are mechanical handling layout, wet milling and steeping, refining and final filling. Clean utilities are deionized water and CIP solutions.

Project Experience prior to Fluor Daniel:

The Badger Company, Cambridge, MA 1975 - 1979

Engineering Mechanical Lead

Styrene Monomer Facility: Taiwan Government.

Engineering, Procurement, and Construction Management

Responsible for all phases of piping process design, utility and waste management systems. Production of construction and fabrication documents. Construction interface.

Processes are:

Liquid fractionation columns, kettle vessels, gas compression.

Utilities are superheated steam, chilled water, glycol, process air compression and tank farm storage.

The Catalytic Company, Philadelphia, PA 1973 - 1975

Engineering Mechanical Lead

Ventron Corporation: – Trimethylborate Chemical Facility.

Responsible for all phases of piping process design, engineering and construction management. Production of construction and fabrication documents. Resident on site during construction to coordinate construction and home office engineering.

The D.A.T.S Consulting Company, Warrington, England 1966 - 1973

Senior Designer and Checker

Working in a consulting capacity for major UK and European corporations, produced piping studies, process piping drawings, incorporating isometrics, process utilities, civil, structural and mechanical handling sections. Industries served:

Refinery and chemical:

North Sea gas and oil:

Animal fertilizers:

Centrifuge processing of nuclear fuels.

Publications:

International Society Pharmaceutical Engineering (ISPE).

Pre-Engineering Design and Construction: Integrated Transfer Panel Modules.

Fluor Daniel Internal Publications

Engineering Quality and Compliance to cGMP Practice

Compliance to Good Manufacturing Practice Procedures

“Lessons Learned” Interactive Database Covering Engineering, Construction and Validation Data in the Biopharmaceutical Industry from 1980 to the Present

Biopharmaceutical Interdisciplinary (all Discipline) Checking Procedure

cGMP and Engineering Quality Review Procedures for:

Process Architectural Floor Plans;

People, Material, Waste Flow Patterns

Equipment Arrangements

Piping and Instrument Diagrams (P&ID’s)

cGMP\Quality Coordinator Job Description (QA\QC) for Biopharmaceutical Engineering and Construction

Education:

G.C.E. (General Certificate Education)

Joint Matriculation Board

Wellacre Technical College, England.

U.L.C.I (Union of Lancashire & Cheshire Institutes)

Mechanical Engineering Degree (MET)

Stretford Technical College, England.

Training:

Five years indentured technical apprenticeship with David Brown Corporation, England, connected to a co-op program with Stretford Technical College.

Professional Societies:

International Society for Pharmaceutical Engineers (ISPE) Biotech Guide steering committee.

American Society of Mechanical Engineers (ASME) Member of the Bioprocessing Standard Subcommittee

Commonwealth of Massachusetts Master Pipefitters

Security Clearance:

United Kingdom Atomic Energy Authority ‘A’ (British)

Citizenship:

United Kingdom of Great Britain: Citizen

United States of America: Permanent Resident

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