Construction Project

Wallace R. Nelson

***** ***** ******** *** *****, CA 92128 858-***-**** *********@***.***

SUMMARY

Professional Facilities / Engineering Director with over 20 years of experience in directing all aspects of maintenance activities

and construction projects in Manufacturing Environments. Hands on Director of ISO compliant multifunctional departments

including: Facilities, Engineering, EH&S and Calibration. 18 plus years experience in planning including: Space Planning,

Growth Planning, Disaster Recovery, Equipment Life Cycle, 10 Year & Contingency.

* Process Improvement Implementation * Facil/Eng Management in Manufacturing Environments

* Process Flow Development/Implementation * ISO, FDA, EU, AATB, OSHA & DEA Requirements

* 10 Year Growth Plan Development * Construction Management of Manufacturing Facilities

PROFESSIONAL EXPERIENCE

San Diego, CA Contract Manufacturer 2012 – Present

Director, Facilities & Engineering

Directed Facilities & Engineering efforts with a staff of 11 at a 5 building campus with one remote warehouse/distribution

site. Performed site selection and tenant improvement for the warehouse which included 10 year growth planning. TI

included: 2 Modular clean rooms, high rack shelving, 3 walk-in cold boxes, fourteen -80 freezers, new HVAC units, BMS

system, & an Emergency Generator. Performed office remodel and space planning that included adjacency evaluation as

well as future departmental growth allowances. Replaced process critical water purification system and coordinated

insurance reimbursement, implemented flood protection program. Achieved an annual savings of approx. $300K by

bringing work in-house that had been previously out-sourced.

AlloSource; Centennial, CO Device/Tissue Processing Operation 2007 - 2012

Director, Facilities

Directed Facilities operations in three separate manufacturing sites located in three states as well as seven distribution

sites located throughout the country.

• Management: Managed three Manufacturing Facilities in three separate states. Managed consolidation of sites

in Salt Lake City, UT and Cincinnati, OH to Denver, CO. Managed expense budget of $3.4M and capital budget

up to $22.5M. Developed 10 year facilities growth plan based on 10% per year increase in finished product,

developed disaster recovery and strategic utility equipment expansion / replacement strategies

• Process Improvement: Implemented a water reclaim system resulting in an annual savings of approx. $124,000.

Implemented a water treatment skid to improve process water quality for washing operation which eliminated the

need to wash by hand as the city changed water sources. Implemented bulk process gas tanks & bulk acid delivery

system for processing. Implemented an acid waste neutralization skid to maintain EPA compliance. Initiated

additional cost savings projects (Utility usage based) with an annual savings of over $250K.

• Construction/Tenant Improvement: Managed construction of a 67.5K sq. ft, building which consolidated

operations from 3 separate area buildings to one 106.4K sq. ft. campus. Project included an exit strategy, a

complete remodel of the existing facility with no unplanned interruption to on-going operations. Also included

process flow development, & space planning for future expansion. Construction consisted of a new two story

50K sq ft building with office & lab space & a 17.5K sq ft connector building which housed WIP, distribution /

shipping operations with 247 -80 freezers. Total project cost $20.3M. Managed construction of 9 new ISO class 5

clean rooms, an ISO class 6 & 7 sterilization suite and 36.3K sq ft of R&D Labs.

Facilities Manager Skyepharma: San Diego, CA Pharmaceutical Manufacturer 2003 - 2007

Managed on-going facilities maintenance activities and construction projects in FDA regulated manufacturing

environments and R&D Labs in two separate locations. Managed team of nine multi-functional techs & mechanics who

performed maintenance & calibration both in and outside of aseptic processing clean rooms.

• Implemented projects and contingency planning to reduce manufacturing equip. down time including inventory

analysis, redundant systems, & renovation of preventive maintenance program.

• Managed numerous construction projects in R&D laboratory environments including: Creation of negative

pressure R&D bio room, renovation of R&D labs, and transformation of dry to wet lab for process development work.

• Managed construction project to build manufacturing clean rooms for fully intergraded Fill Line conforming to

both FDA & European Standards. Project included: ISO Class 5, 6 & 7 cascading clean rooms, new filler & capper

and start-up of de-commissioned equipment.

Facilities Manager Agensys: Santa Monica, CA Cancer Therapeutics Site 2001 - 2003

(Project Work)

Managed all facilities & equipment maintenance and construction activities for the corporate headquarters in an R&D Lab

& a Fermentation/Purification in a FDA regulated manufacturing environment utilizing in-house work force and

contracted services.

• Managed a $8.6 million dollar design build tenant improvement project creating a validated Fermentation /

Purification Pilot Plant used for Phase I & II clinical production. Negotiated a $200,000 reduction in construction

project cost.

• Project scope included: Implementation of new purified water & steam systems, autoclave, glass washer, clean

dry compressed air, cold boxes, lay-out configuration, class 10K & 100K (ISO 5 & 6) clean room environments,

chilled water system, process gas manifold systems including LN2; N2, O2 & CO2.

• Managed construction of suites of vivariums designed to house separate strains of genetically engineered animal

models and act as an operating theater with minimal impact to R&D lab activities in a conjoining room.

Facilities Manager Integra NeuroCare; San Diego, CA Medical Device Manufacturer 1996–2001

Managed all facilities and equipment maintenance activities and construction projects and for three buildings in two

locations ensuring FDA compliance for the facility & all maintenance activities. Sites included a manufacturing facility

with two FDA regulated Clean Rooms, and R&D lab space with one Class 10,000 Pilot Lab.

• Within first quarter of joining the company orchestrated a planned shutdown of manufacturing clean rooms for re-

modeling, changes included: up-grading room classification to class 100,000, Process Flow lay-out, HVAC air

balancing / cascading, humidification control, electrical, vacuum, compressed gas & air lines and re-validation.

• Additional projects included: construction of two new clean rooms. A complete re-model of R&D labs and office

space. Installation of an RO/DI water system, card key access system, and compressed air drying system. Achieved

an annual saving of $ 185,500.00 through improvement projects and bringing services in-house that had previously

been out-sourced.

EDUCATION

Diploma: Computer Technology, North County College, Escondido, CA.

Continuing Professional Education: Maintenance Management, Maintenance Planning & Scheduling, Total Predictive

Maintenance, Problem Solving, Project Management, Calibration Fundamentals & Best Practices, OSHA 29 CFR Part

1910 Standards For General Industry at SDSU, HVAC and Controls Management, AutoCAD. ISPE Seminars Including:

GMPs for Facility Design, Construction and Maintenance & Commissioning and Qualification for Pharmaceutical

Facilities and Equipment.

Noteworthy Projects/Accomplishments

Process Improvement

Implemented a water reclaim skid resulting in an annual savings of approx. $124,000.

Implemented a water treatment system to improve process water quality for washing operation.

Implemented bulk process gasses & bulk acid delivery system for processing operations.

Implemented an acid waste neutralization skid to maintain EPA compliance.

Process flow & strategic eq. replacement plan development, space, & equipment redundancy planning.

Maintenance shutdown planning, management.

Business continuity planning; move planning, coordination & management.

Developed disaster recovery/contingency plans, & strategic utility equipment expansion/replacement strategies.

Installation of validated Pharmaceutical Processing Equipment Including: RO/DI, WFI, PSG, CIP, Autoclaves, Glass

Washers, BMS, Chillers, Vacuum, and Bulk Process Chemical/Gas Delivery Systems… in FDA environments.

Led cross functional team to define and create optimal process flow when combining 3 locations into one campus.

Construction

Managed construction of a $22.5 M / 67.5K sq. ft, building which consolidated operations from 3 separate area buildings

to one 106.4K sq. ft. campus. Ahead of schedule, under budget. Denver, CO.

Managed remodel of 38.9K sq ft pharmaceutical manufacturing site with no unplanned interruption to on-going

operations. Denver, CO.

Managed construction of 9 new ISO class 5 clean rooms, a sterilization suite in a fully operational FDA manufacturing

site with no unplanned interruption to on-going operations and 46K sq ft of cGLP, Micro & Testing Labs. Denver, CO.

Managed construction project to build manufacturing ISO Class 5, 6 & 7 clean rooms for fully intergraded Fill Line

conforming to both FDA & European Standards. San Diego, CA

Managed a $8.6 million dollar design build tenant improvement project creating a validated Fermentation / Purification

Pilot Plant used for Phase I & II clinical production. Los Angeles, CA

Managed construction of vivarium housing xeno & skid animal models Los Angeles, CA.

Managed construction & Tennant Improvement Projects of multiple GLP Labs including: Wet / Dry Labs, Negative

Pressure Labs, Microbiology & Testing Labs with & without ISO rated clean rooms . San Diego, CA, Los Angeles, CA,

Denver, CO.

Professional Activities

ISPE presentations on Construction Project Management in FDA Regulated Environments Denver, CO.

Delivered a presentation on “Selecting Maintenance Management Software” at the National Plant Engineering &

Maintenance show; Chicago, IL.

Delivered a presentation on “Implementing Maintenance Management Software” at the National Plant Engineering &

Maintenance show; Anaheim, CA.

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