Wallace R. Nelson

***** ***** ******** *** *****, CA 92128 858-***-**** um8nva@r.postjobfree.com

SUMMARY

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

and construction projects, with 18 plus years in GMP Pharmaceutical/Biotech Manufacturing Plants & GLP environments.

Hands on Director of GMP compliant multifunctional departments including: Facilities, Engineering, EH&S and Calibration.

18 plus years experience in planning including: Growth, Disaster Recovery, Equipment Life Cycle, 10 Year & Contingency.

* Process Improvement Implementation * Facilities Management GMP Pharmaceuticals & Device

* Strategic Equipment Utilization Planning * FDA, EU, AATB, ISO, OSHA & DEA Requirements

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

PROFESSIONAL EXPERIENCE

Althea Technologies; San Diego, CA Contract Manufacture 2012 – Present

Director, Facilities & Engineering

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

site. Performed site selection and tenant improvement for the cGMP warehouse, TI included: 2 walk-in cold boxes,

fourteen -80 freezers, new HVAC units, BMS system, & Emergency Generator. Performed office remodel increasing

seating capacity by 50%. Revalidated damaged WFI system, implemented flood protection program, installed one new

R&D autoclave. 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 FDA regulated GMP device/tissue processing sites located in three states as

well as seven distribution sites located throughout the country.

• 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 GMP processing. 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 17.5 sq ft connector building which housed calibration and

distribution / shipping operations. 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 GLP, Microbiology & Testing Labs.

• Process Improvement: Implemented an autoclave 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 which

eliminated the need to wash by hand as the city changed water sources. Implemented bulk LN2/N2 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

• Management: Managed three GMP 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 donors, developed disaster

recovery and strategic utility equipment expansion / replacement strategies.

Skyepharma; San Diego, CA Pharmaceutical Manufacturer 2003 - 2007

Facilities Manager

Managed on-going facilities maintenance activities and construction projects in pharmaceutical 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.

• 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.

• 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.

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

analysis, redundant systems, & renovation of preventive maintenance program

Agensys; Santa Monica, CA Cancer Therapeutics Development (Project Work) 2001 - 2003

Facilities Operations Manager

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

& a Fermentation/Purification GMP 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 WFI, PSG, 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

Integra NeuroCare; San Diego, CA Medical Device Manufacture 1996–

2001

Facilities Manager

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

locations ensuring GMP compliance for the facility & 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 10,000, 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 $ 185,500.00 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

GMP 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 GMP 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 GMP 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 of two class 10,000 clean rooms, instrumentation and an animal operation lab. Complete re-model

of R&D labs and office space. San Diego, CA.

GMP Process Improvement

Implemented an autoclave 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

Implemented bulk LN2/N2 tanks & 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 GMP Equipment Including: RO/DI, WFI, PSG, CIP, Autoclaves, Glass Washers, BMS, Chillers,

Vacuum, and Bulk Process Chemical/Gas Delivery Systems… in GMP environments.

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

Professional Activities

ISPE presentations on Construction Project Management in GMP 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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