Construction Maintenance

Wallace R Nelson ***** Sky High Rd Escondido, CA *2125 760-

***-**** *********@*****.***

SUMMARY

PROFESSIONAL FACILITIES/ENGINEERING DIRECTOR WITH OVER TWENTY YEARS OF

EXPERIENCE IN MANAGING ALL ASPECTS OF MAINTENANCE, ENGINEERING, PROCESS

IMPROVEMENT, AND CONSTRUCTION PROJECTS, IN PROFESSIONAL ENVIRONMENTS.

HANDS ON DIRECTOR OF COMPLIANT MULTIFUNCTIONAL DEPARTMENTS INCLUDING:

FACILITIES, ENGINEERING, EH&S AND CALIBRATION. TWENTY PLUS YEARS OF

EXPERIENCE IN PLANNING INCLUDING: GROWTH, DISASTER RECOVERY, EQUIPMENT LIFE

CYCLE, TEN YEAR & CONTINGENCY.

Process Improvement Implementation Project Management,

Equipment Installation

Space Planning / Office Remodels Fire, EPA, ISO, OSHA &

DEA Requirements

10 Year Growth Plan Development Construction

Management of Facilities

EXPERIENCE

ALTHEA - SAN DIEGO, CA 05/2012 -03/2015

Director, Facilities & Engineering

Managed all on-going Facilities, Engineering, and EH&S efforts with a staff

of 12 at a 5 building campus with one remote warehouse/distribution site.

Represented Facilities and Engineering in all audits.

Managed all building related vendor performed services.

Performed space planning as well as several office remodels increasing

seating capacity by 30% while delaying the cost of leasing additional

space.

Managed construction of warehouse/distribution site including: walk in cold

boxes, modular clean rooms emergency power, BMS and high bay shelving.

Revalidated damaged Purified Water System, coordinated insurance

reimbursement, implemented flood protection program, installed new process

equipment.

Achieved an annual savings of approximately $300K by bringing work in-house

that had been previously out-sourced.

AlloSource - Centennial, CO 2007 - 2012

Facilities Director

Management: Managed Facilities, Engineering, Calibration, and EH&S in

three Facilities in three separate states as well as seven distribution

sites throughout the country. Managed consolidation of sites in Salt Lake

City, UT and Cincinnati, OH to Denver, CO. Managed expense budget of

$5.4M and capital budget up to $22.5M. Developed 10 year facilities growth

plan based on 10% per year increase in processes, developed disaster

recovery and strategic utility equipment expansion / replacement

strategies.

Process Improvement: Implemented a water reclaim skid resulting in an

annual savings of approximately $124,000. Implemented a water treatment

skid to maintain EPA compliance. Implemented bulk LN2/N2 tanks and all

laboratory equipment. 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 SF

building which consolidated operations from 3 separate area buildings to

one 106.4K SF. campus. Project included an exit strategy, a complete

remodel of the existing facility with no unplanned interruption to on-going

medical procedures. Also included flow development, & space planning for

future expansion. Construction consisted of a new two story 50K SF

building with office & lab space & a 17.5K SF 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 and 7 sterilization suite and 36.3K SF of Microbiology &

Testing Labs.

Skyepharma - San Diego, CA 2003 - 2007

Facilities Manager

Managed on-going facilities maintenance activities and construction

projects in medical manufacturing environments and R&D Labs in two separate

locations. Managed team of nine multi-unctional technicians and mechanics

who performed maintenance and calibration both in and outside of aseptic

clean rooms.

Implemented projects and contingency planning to reduce equipment down time

including inventory analysis, redundant systems, and 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

integrated Fill Line conforming to both FDA & European Standards. Project

included: ISO Class 5, 6, and 7 cascading clean rooms, new filler & caper

and start-up of de-commissioned equipment.

Agensys - Santa Monica, CA 2001 - 2003

Facilities Operations Manager (Project Work)

Managed all facilities and equipment maintenance and construction

activities for the corporate headquarters in an R&D Lab and a

Fermentation/Purification 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 and III clinical production. Negotiated a $200,000 reduction in

construction project cost.

Project scope included: Implementation of new WFI, PSG, autoclave, glass

washer, clean dry compressed air, cold boxes, lay-out configuration, class

10K and 100K (ISO 5 and 6) clean room environments, chilled water system,

process gas manifold systems including LN2; N2, O2 and 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.

Integra NeuroCare - San Diego, CA 1996 - 2001

Facilities Manager

Managed all facilities and equipment maintenance activities and

construction projects and for three buildings in two locations ensuring FDA

compliance for the facility and all maintenance activities. Sites included

a manufacturing facility with two Class 10,000 (ISO 6) 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, lay-out, HVAC air balancing /

cascading, humidification control, electrical, vacuum, compressed gas & air

lines and re-validation.

Additional projects included: construction of two class 10,000 clean rooms,

instrumentation and an animal operation lab. 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 through improvement projects and bringing services in-house that

had previously been out-sourced.

EDUCATION

NORTH COUNTY COLLEGE - ESCONDIDO, CA 1985

Computer Technology

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.

Projects/Accomplishments

Process Improvement

Installation of validated Medical Equipment Including: RO/DI, WFI, Purified

Water, CIP, Autoclaves, Glass Washers, BMS, Chillers, Vacuum, and Bulk

Chemical/Gas Delivery Systems, Boilers, Clean Compressed AIr...

Identified and resolved major equipment down time issue resulting in a 35%

increase in availability

Implemented a water reclaim skid resulting in an annual savings of approx.

$124,000.

Implemented a water treatment skid to improve process water quality for

washing operation.

Installation of all laboratory equipment

Implemented an acid waste neutralization skid to maintain EPA compliance.

Developed process flow & strategic eq. replacement plan, space planning, &

equipment redundancy/back up plan.

Led cross functional team to define and create optimal process flow when

combining 3 locations into one campus

Maintenance shutdown planning, management.

Business continuity planning, move planning, coordination & management.

Developed disaster recovery/contingency plans, & strategic utility

equipment expansion/replacement strategies.

Construction

Managed construction of a $22.5 M / 67.5K SF building which consolidated

operations from 3 separate area buildings to one 106.4K SF. campus, ahead

of schedule, under budget.

Managed construction of 9 new clean rooms, a sterilization suite in a fully

operational Medical manufacturing site with no unplanned interruption to

on-going operations.

Managed construction project to build manufacturing clean rooms for fully

intergraded Fill Line conforming to both FDA & European Standards.

Managed remodel of 38.9K SF Medical manufacturing site with no unplanned

interruption to on-going operations.

Managed a $8.6 million dollar design build tenant improvement project

creating a validated Fermentation / Purification Pilot Plant used for Phase

I, II & III clinical production.

Managed construction of Medical Distribution site including emergency

power, walk in cold rooms, BMS, Modular Clean Rooms and High Bay Racking

Managed construction of vivarium housing xeno & skid animal models

Managed construction & Tenant Improvement Projects of multiple Medical Labs

including: Wet / Dry Labs, Negative Pressure Labs, Microbiology &

Testing Labs with & without ISO rated clean rooms.

1 Professional Activities

ISPE presentations on Construction Project Management in Federally

Regulated Environments Denver, CO

Delivered a presentation on "Implementing Maintenance Management Software"

at the National Plant Engineering and Maintenance show.

Los Angeles, CA

Delivered a presentation on "Selecting Maintenance Management Software" at

the National Plant Engineering

and Maintenance show.

Chicago, IL

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