Dale Barnes, LT(SS), USN ret.

**** ******* **** **** . ******** TN 38002 . 901-***-**** (P) . 901-389-

**** (Cell) . abnefk@r.postjobfree.com

Executive Summary

Engineering Management professional with extensive equipment, operational,

maintenance, and validation expertise in a cGMP pharmaceutical environment.

Large and small project experience with new equipment, facility

modifications, innovative product launches, and Lean concept applications.

Proven abilities with Six Sigma, DMAIC, 5S, FMEA, Kaizen, and other Lean /

SPC processes. Exceptionally effective in a multi-tasking environment

bringing new processes on-line using a diverse skill set containing Team

building, training, SOP generation, regulatory (validation) documentation

generation, and change management.

Proven abilities as a Project Manager in multiple industries:

. Pharmaceutical: multiple projects up to $7 million in scope managed

from concept to commissioning. Handled all areas from definition,

FMEA, competitive bid requests, specifications, testing, validation,

and operator training.

. Nuclear: Primary coordinator / scheduler for ship's force for the $14

million dollar shipyard overhaul of the MTS626. Managed over 3000

maintenance items for 4 maintenance divisions containing 300 personnel

for this 6 month overhaul.

A wide variety of technical and planning skills on various equipment and

processes including:

Packaging and process Reliability Centered Formal Work Procedure

machinery Maintenance programs generation

PLC and Lock-Out / Tag-Out, Humidity / Temperature

electro-mechanical Confined Space, and other control systems

controls OSHA

Federal / State / Local Pneumatic / Hydraulic Radiological / HazMat

agency interaction systems controls

Hydrostatic testing Water purification systems Clean room

HVAC systems Motors / generators SAP PM, MM, IM modules

Electrical distribution Centrifugal and positive Cleanliness controls:

systems displacement pumps Nuclear and FDA

Education

MBA, Florida Tech (in progress) Current GPA 4.0

BS Materials Science and Engineering w/chemistry minor, Virginia Tech, cum

laude, GPA 3.44

AA, Columbia College, GPA 4.0

Certified Packaging Professional with the Institute of Packaging

Professionals, 2009

PROFESSIONAL EXPERIENCE

McKesson/RxPak 2003 -

Present

Engineering Director (2006-2009) for this Fortune 15 company. Directed

maintenance, repair, and compliance with OSHA, FDA, DEA, USDA, and cGMP

requirements of the facility, production equipment, HVAC systems and

controls, pneumatic systems, clean rooms, and miscellaneous support

equipment for a pharmaceutical contract packaging operation.

. Authored numerous validation and qualification documents saving the

company over $100,000. The quality of the documents was verified by

multiple customer and federal audits with no identified deficiencies.

. Implemented the Planned Maintenance module of the SAP system including

complete set up of the functional locations, all equipment, failure

codes, damage codes, material masters, and bills of materials.

. As a member of the CAPA Team, led the efforts to reduce re-works from

seal issues. Used 6Sigma and other Lean methods to identify and

eliminate variability reducing reworks for seal issues by over 70%.

. Project Manager for an innovative prescription drug compliance package

product launch and associated machinery with a budget of over $2

million. Products ready prior to anticipated launch date and within

budget.

Operations Manager (2004-2006) Managed all aspects of operations including

production, production and maintenance planning, maintenance, facility, and

warehouse personnel (43 of 75 personnel in the facility). Production

equipment consisted of 5 solid dose bottling lines, 3 thermoforming lines,

and 1 manual packaging line.

. Reduced change-over times from an average of 5 hours down to less than

1 hour thereby reducing the minimum profitable batch size and

increasing plant capacity without adding expense.

. Project Manager for 3 complete blister production lines from concept,

cost analysis, capital funds request and approval, vendor selection,

installation, validation, and all testing. (Over $7 million in total

cost). All ahead of schedule and under budget.

. Implemented a new scheduling paradigm to direct specific sizes to

certain lines. This increased line efficiencies by reducing set-up

time and led to a measured increase in throughput of more than 10%.

. Performed a pilot study to determine manning needs for the production

lines. Reduced plant operation to a single shift with no loss in

production but with added flexibility for employee vacation

scheduling. This was a direct reduction in expenses of over $30,000

in shift differential pay and more than $100,000 in utility savings.

. Instituted a cross training regime for the warehouse personnel such

that any member could perform all required duties. Allowed more

flexibility in the response to unforeseeable personnel issues.

. Mentored 3 successful Green Belt projects with a savings of more than

$400,000 annually.

Maintenance Manager (2003-2004) Covered all aspects of facility and

production maintenance including documentation requirements.

. Leveraged existing talent in the maintenance department against

specialty machine shop expenses to justify expansion of the

maintenance area to include a basic machine and welding shop. The

equipment was purchased at a substantial savings from an alternate

source for $50,000 - generated savings have tracked in excess of

$40,000 per quarter.

Covidien Healthcare (Formerly Tyco Healthcare) 2001 -

2003

Senior Manufacturing Engineer tasked with managing all aspects of machinery

maintenance, selection, installation, and qualification of pharmaceutical

packaging equipment in the facility. Liquids, solid dose, and

thermoforming packaging lines were all in operation at this facility.

. Managed the start-up, including operator training, of the newest high

speed line. This line exceeded the previous capacity of the plant on

its own.

. Developed a training plan for new hire mechanical personnel to allow

them to be immediately useful and progressing to full set-up

technician with-in 6 months as an integrated part of expanding the

maintenance group from a part time 3 shift support group to a 24/7

support group.

. Determined plant savings to purchase new equipment to bring contracted

work back "in house" and save an estimated $800,000 per year.

. Team Captain of one of 5 Lean Manufacturing Teams that implemented

over $600,000 of annual savings in the first year alone.

. Led or participated in multiple Kaizen events to reduce changeover

times by 70%.

. Team captain / project manager for 3 other complete packaging lines

from conception to completion.

US Navy 1981 - 2001

Naval Officer - Nuclear Submarine Force

Materials Officer (1998 - 2001): Responsible for 4 departments of 16

personnel and their supervisors charged with the safe and timely repair and

preventive maintenance of a 40 year old nuclear power plant and its support

equipment. Additionally responsible for a maintenance force of another 5

crews of 52 personnel each during planned shut down periods.

. Planned and directed periodic 3 week shutdowns containing upwards of

700 planned repairs.

. Hand picked by the Officer in Charge over 9 other Shift Engineers to

perform this demanding task.

. Installed procedures to minimize rework by using MS Project for

scheduling to save an average of 90 man-days of production per year.

. Fully implemented hazardous material disposal streams into formal work

procedures for the first time on site. This became the routine for

the site.

Shift Engineer (1997 - 1998): Supervised and directed the operation of a

nuclear propulsion plant for the purpose of training future technicians for

the Navy. Responsible for the initial reaction to numerous emergency

situations associated with the reactor plant, personnel, hazardous

materials, and hurricane preparedness.

. Awarded both the Crew Training and Training Awards for superior crew

performance and Team Effort.

. Recognized as excellent in troubleshooting and directing the repair of

mechanical and electrical systems led to selection as the Materials

Officer.

Division Officer and enlisted Machinist's Mate prior to 1997 on different

nuclear submarines and at training facilities.

. Designed and implemented an innovative system using commercial off the

shelf components to link periscope video to a PC then to a battle

group commander. A variant of this was made standard a few years

later.

. Hand picked by the CO to direct the submarine actions in tactical and

readiness exams.

. Established a standardized format for electrical division maintenance

to minimize re-work and administration requirements.

. Selected from over 1000 candidates as one of 198 for the Enlisted

Commissioning Program

. Promoted to Chief Petty Officer in 9 years.

. Junior man assigned to instruct at Naval Nuclear Power School.

. First E-5 to qualify as the senior enlisted engineering watch

supervisor.

. First of all initial crewman to qualify in submarines aboard USS

AUGUSTA.

. Initial crew aboard USS Augusta for new construction and testing

through commissioning.

Further Training / Certification / Professional Achievements

. Numerous seminars for manufacturing excellence: Lean Manufacturing,

RFID - Track and Trace, 6Sigma (mentored 4 green belt and 2 black belt

projects), Kaizen (over $200,000 in annual savings from a single

project), 5S, DMAIC, FMEA, and more.

. Very proficient in all MS Office applications including MS Project.

. Top Secret / SCI security clearance (inactive / clearable)

. Retired US Naval Submarine officer with enlisted experience through

MMC(SS)

. Naval qualifications include: Nuclear Engineer Officer, Nuclear

Weapons Safety and Security, Communications Security Materials

Custodian, Sealed Authentication System, 3M Administrator, QA

Inspector, and many others.

Other Interests

. Rebuilding Jeeps, trucks, and older European sports cars (old Porsches

and Alfas are the best).

. Building and flying radio controlled airplanes

. Woodworking

Contact this candidate