Frederick M. Denning

Ph: 760-***-****

E-mail: abhiog@r.postjobfree.com

Summary:

I have a true passion for working in Facilities. My work ethics are based

around working as hard and as long as necessary and doing whatever it takes

to keep the facility safely operational and well-maintained to support

corporate goals. I have over 19 years of experience working in facilities

operations, maintenance, new construction, renovation/tenant improvement

and site support within the biotech/pharmaceutical/medical device and

hospital industries. The foundation of my experience was preceded with six

years in the US Navy where I served as a Boiler Technician and developed

the fundamentals of mechanical engineering systems and maintenance.

Five years subsequent to my military service and after working hands on as

a facilities technician, I began to work on my education and work toward a

degree in Business Management which I achieved in 2002. My education

combined with my hands on and technical experience is perhaps my strongest

attribute as a Manager.

As my career has progressed over the years, I've worked hard and stayed

very close to technical issues, stayed involved with complex

troubleshooting and often times even performed repairs, replacement or

overhauls on facility/plant equipment/systems/controls. Now in the

management track of my career I continue to stay close technical issues as

it's a passion of mine, however, in recent years, I've focused more on

coaching and developing those I manage/mentor to help them learn and

understand the systems/equipment that I've mastered over the years.

EMPLOYMENT HISTORY:

Roka Bioscience Jan 2010 - July 2010

San Diego, CA 92121

Manager, Facilities Services

. Project Management - Partnered with the Property Owner/Manager,

Architect, General Contractor, Mechanical Contractor and Roka senior

management during the tenant improvement phase of the project. This

involved renovating 60,00 sq/ft of clean labs, mfg space, warehouse

and office areas and all mechanical systems to meet move-in date and

manage budget to targets. Additionally selected the Siemens "Apogee"

building automation system configuring it for optimal facility

operations, critical alarm notification and energy efficiency

. Facilities Services - Established facilities services work flow

processes and procedures and implemented an on-line work order system

via the company intranet, established outsourced vendor

support/contracts, worked directly with internal customers providing

support where needed. Worked daily on pumps, boilers, chillers and

supporting mechanical systems and equipment, including maintenance of

a robust water treatment program to preserve systems longevity and

assets life

. Instrument/Calibration Manager - Established processes and procedures

necessary to support over 1,000 instruments for tracking and routine

calibration activities and compliant with FDA regulations/CFR's

. Environmental Health & Safety Manager - Established the injury &

illness prevention program, managed MSDS inventory, coordinated waste

handling/hauling and disposal, managed the OSHA 200 log, developed

safety metrics to report on the overall Safety program sot senior

management, developed safety committee, managed all site permitting

for the City/Fire/State/Federal requirements and managed all safety

equipment across the site

. Security Manager - Lead procurement of security system hardware (card

access equipment and internal/external cameras) and was responsible to

bid installation of the system, configuration and ongoing support of

the system. Also implemented key control strategy and managed/issued

all access across the site

. Shipping and Receiving Manager - Responsible for coordinating shipping

and receipt of supplies, raw materials and inventory

Denzephia Inc. May 2008 - Jan 2010

Fallbrook, CA

President/CEO - Pharmaceutical Compliance Consultant

I started and was the sole owner/operator and functioned as an independent

consultant responsible for providing compliance solutions in the

Pharmaceutical, Medical Device and Biotech industries under the facilities

umbrella. In this role I would use my experience haven been audited by

the FDA many times before, to help companies understand their vulnerability

and system gaps and help to bring their programs into compliance with

FDA/EMEA/EU/ISO requirements. Another service I would provide is physical

site inspections of clean rooms, central plant/mechanical systems and other

classified space to identify risks and potential compliance violations.

Additionally, I would routinely review processes, operating procedures and

work flows and would assist in implementing necessary changes to improve

costs and/or overall compliance with CFR's.

IDEC/BiogenIDEC/Genentech Inc. Feb 2001 - May 2008

Associate Director, Facilities Services

San Diego/Oceanside, CA

. Functional responsibilities and sub departments overseen included:

o Plant/Utilities Operations/Maintenance: Plant/Utilities operations,

production equipment maintenance and HVAC

o Real Estate Management: Strategic space planning, site

master planning and all facilities services

contracts and vendor management

o Metrology/Instrumentation: Metrology and Instrument

Services. Routine calibrations 10,000+

instruments

o Maintenance Systems: MRO Inventory/Parts management,

CMS/CMMS information systems,

all cGMP compliance documentation and QC/R&D Labs support and

autoclave and glass wash functions

. Provided leadership coaching and career/personal development for

teams and individuals and had direct supervision and management over

team leads in each functional area

. Developed and reported on departments budgets to meet corporate

objectives

. Responsible for Facilities department on-site leadership during

construction, of new, 500,000 sq/ft, multi-building campus style

facility in Oceanside, CA with over 100,000 sq/ft of classified,

"clean room" spaces throughout manufacturing. This included review,

approval, install oversight and maintenance system implementation

. Built Facilities services organization by hiring over 30 FTEs in

partnership with Human Resources. This involved resume review,

candidate selection and physical interviews

. Ensured overall continuous cGMP and GLP inspection readiness and FDA

compliance for Facilities Services processes, people, systems and

documentation

. Functioned as Facilities department lead during FDA/EMEA/EU/State and

regulating agencies inspections resulting in no 483's

. Functioned as Facilities department leader on SAP integration of all

facilities work flows and processes from existing

facilities/maintenance/calibration systems into SAP, Enterprise

Resource System

. Responsible for vendor oversight/management as well as contract

negotiations with Strategic Sourcing to leverage and reduce the

overall assets total cost of ownership (TCO)

. Developed and reported on department business fundamental metrics to

senior management to measure department performance

. Lead Facility planned shutdown projects coordinating efforts and

overseeing completion to project schedule as not to impact

manufacturing

. Lead teams though Oliver Wight, Class A achievement and implement

"Lean Manufacturing" principals including Kanban, 5S and related DMAIC

processes implementation

Quidel Corporation Aug 98 - Jan

01

San Diego, CA

Manager, Facilities/Maintenance/Calibration

. Overall responsibility for all production facilities and production

equipment maintenance and calibrations including: Plant/Utilities,

HVAC, MEP systems, lyophilization, dehumidification, dry rooms, clean

rooms, auto-assembly, packaging, labeling, and pouching equipment

. Researched, procured and contracted installation of new Building

Automation System (BAS), selecting Johnson Controls "Metasys" system.

Configured system for optimal building operations, critical alarm

notification energy efficiency and automated reports generation

. Manage planning, budgeting, capital project evaluation/analysis and

tracking for $2 MM operating/expense budget and $6 MM capital budgets

. Oversaw Manufacturing Engineering group in support of all production

and manufacturing equipment as well as Facilities Maintenance group in

support of all facilities and plant engineering issues

. Ensured that programs and documentation compliance in accordance with

cGMP, EPA, and ISO 9000 regulations in 72,000 sqft invitro-diognostic

device manufacturing facility and 25,000 sqft medical device

manufacturing facilities as well as 20,000 sqft office space facility

in multiple locations

. Responsible for site security at all facilities/sites controlling and

integrating card access, and CCTV systems as well as physical key

distribution system

. Managed activities related real estate, new facilities appropriation

and acquisition, design/construction and relocation as well as all

tenant improvements and project management

Medtronic Interventional Vascular May 96- Aug 98

San Diego, CA

Facilities/Maintenance Supervisor

. Managed all facilities/maintenance employees (9)and external

contracted services in 120,000 sq/ft medical device manufacturing

facility

. Managed all aspects of facilities, plant/utilities and production

equipment maintenance across the Facilities organization. This

included all production equipment, plant/utilities, clean rooms,

labs, warehouse and office areas, supporting over 600 customers

. Worked closely with the Property Management company getting all TI's

approved appropriately with the proper permitting

. Conducted routine troubleshooting, physical repairs and overhauls of

facility/utility/plant equipment and instruments

. Operated the facility building automation system, Siemens "Apogee"

system. This involved configuration and programming of the system to

achieve optimal operations, equipment time of day schedules for energy

efficiency, critical alarm reporting and automatic system report

generation

. Managed department budgets, goals and objectives, staffing plans and

department metrics reporting

. Managed multiple facility tenant improvements improvement projects

. Managed EHS&S functions, establishing processes, procedures and

business reporting to senior management

. Managed security function and security system

. Partnered with IT/IS on operations and maintenance of main phone

switch and all adds, moves and changes

UCSD Medical Center, Thornton Hospital Feb 93 - May 96

San Diego, CA

Facilities Engineer - Systems Specialist

. Worked during facility construction and start up in the Facilities

group. Conducted physical rounds, inspections, repairs and

maintenance of all facility, plant/utility and hospital equipment

. Eventually functioned as Facilities Team Leader in a cross-functional,

self-directed work team environment and was responsible for mechanical

procurement coordination, budgeting and water treatment program for

all mechanical systems

. Worked to support implementation of work order management

system/process/program. Additional responsibilities included

operation and maintenance of all facilities and plant/utilities

equipment/systems, preventative/predictive maintenance and repairs as

well as energy management via automated building management system

(Johnson Controls "Metasys" system) and staffing

coordination/assignment to support 24/7/365 operation schedule

United States Navy Sept 86 -

Sept 92

California (Long Beach and San Diego, CA)

Boiler Technician - Propulsion Engineering

. Served aboard - USS New Jersey (BB-62) in Long Beach, CA and USS McKee

(AS-41) in San Diego, CA

. Served in Operation "Desert Storm" - 1991

. Attended various specialized technical schools during tenure

. Honorably discharged from the military with numerous meritorious

awards and Good Conduct

. Operated and maintained ships propulsion and auxiliary support systems

and equipment

. Lead ships lube oil quality management program

. Functioned as plant lead (Top Watch) in the ships boiler rooms,

leading and supervising all supporting individuals

Education and Certifications:

. Bachelors of Science degree - Business Management - University of

Phoenix - San Diego, California

. Multiple leadership, management and cGMP training courses and

certificates

. Proficient in most business computer software programs,

. Multiple training and certificates in personal development, change

management and employee development

. Multiple training on computer various programs - MS Visio, AutoCAD LT,

Project, Power Point, Excel, Word etc.

. Familiar with most ERP systems (SAP, BAAN, etc) as well as specialized

CMMS systems specific to Facilities/Maintenance/Calibration Management

(DataStream - MP2/7i, CalMan, ProCAL, PM-SAP, etc)

. Siemens "Apogee" and Johnson Controls "Metasys" system operator

training

Professional Affiliations:

. International Society of Pharmaceutical Engineers (ISPE)

Professional/Personal References:

. Confidentially available upon request

Contact this candidate