Manager Engineer, Maintenance Manager, AS9100D Auditor

Athens, AL ***** 256-***-**** ***********@*****.***

Lea Kinney, MBA, BSEE

Summary

Senior Engineer with extensive experience in management, facilities, maintenance, quality and technical support across diverse industries including petrochemical continuous and batch processing, discrete manufacturing, facilities/utilities, pharmaceutical oral solid dose, semi-solid, and liquids manufacturing and packaging.

Core Competencies

Maintenance Management

Facilities Management

Preventive & Predictive Maintenance Strategies

Failure Mode & Effect Analysis (FMEA)

New Plant Startup

Capital Project Management

Equipment Specification & Qualification

Good Manufacturing Practices (cGMP)

Quality Management System (QMS)

Overall Equipment Effectiveness (OEE)

Maintenance, Repair, & Operations (MRO) Procurement

Manage hourly & salaried staff

Professional Experience

PAR/ENDO/Qualitest Pharmaceuticals, Huntsville, AL October 2008 – August 2017

Endo is a pharmaceutical manufacturer of generics and specialty branded medicines. In September, 2015, Endo International acquired Par Pharmaceutical merging the business with Endo's Qualitest.

Sr. Project Engineer, February 2017 to August 2017

Identified and implemented improvement projects resulting in a 10% improvement in OEE

Supported project engineers with design, specification, and facility related decisions

Conducted root cause analysis utilizing FMEA

Recommended and implemented Corrective Action / Preventive Action (CAPA) related to identified non-conformances

Managed documentation change control for Engineering Standard Operating Procedures, Engineering Change Requests, and Equipment Qualification Protocols and addendums

Authored as well as reviewed testing protocols for equipment qualification

Director of Reliability & Calibration, Aug 2014 to February 2017

Oversaw implementation of Vendor Managed Inventory (VMI) MRO storeroom (~25 contract employees) resulting in reduction of 13 Full time employee headcount (~$15 Million annual spend)

Led effort to Implement Asset Management Master Plan

Directed maintenance organization for three manufacturing sites (~100 direct/indirect employees)

Supervised calibration/metrology activities for three manufacturing sites (~15 employees)

Developed metrics and reporting tools to measure and monitor maintenance and metrology performance against business and quality objectives

Supported Capital Project Implementation

Continued Sr. Asset Manager responsibilities

Sr. Asset Reliability Manager, May 2012 to August 2014

Facilitated the selection and implementation of Computerized Maintenance Management Software (CMMS) Blue Mountain Regulatory Asset Manager (RAM) to manage the execution of Maintenance and Calibration Work

Developed Asset Management Master Plan including the following elements: organizational readiness, CMMS functionality, planning & scheduling, work management, inventory management, metrics & performance improvement, and maintenance and reliability strategy

Implemented predictive maintenance (PdM) activities including Infrared Thermography, Ultrasound Analysis, Vibration Analysis, and Tribology

Developed annual maintenance and facilities budget

Led maintenance and metrology organization for three manufacturing sites (~115 employees)

Negotiated Maintenance Contracts for preventive maintenance on all facilities equipment such as boilers, air compressors, HVAC Equipment, fire suppression and protection, purified water system, and diesel generators

Equipment Qualification & Engineering Manager, Oct 2008-May 2012

Supported the capital investment necessary to double production of Huntsville facility from 4 Billion to over 8 Billion doses annually

Authored program documents defining the testing requirements for the qualification of capital assets

Developed and managed Equipment Qualification and Validation program

Led Capital Project planning and execution including the recruitment of staff engineers

Generated User Requirements, Functional Design Specifications, Commissioning Protocols, and Qualification Protocols for Capital Project equipment acquisitions

Solicited, reviewed and recommended competitive bids for Capital Project acquisitions

Managed and supervised Calibration activities including setting frequencies, reviewing calibration records, and setting critical process parameter tolerances

Cinram Manufacturing, Huntsville, AL June 2000 – October 2008 Cinram Manufacturing was a Toronto, Canada-based manufacturer of pre-recorded Blu-ray Discs, DVDs, CD-Audio, CD-ROMs, VHS tapes and audio cassettes. In 2015 Technicolor acquired Cinram’s assets.

Facilities Engineering Manager

Supported strategic planning and forecasting related to space requirements, production capacities and forecasted volumes

Oversaw all aspects of facilities management at a 1.5 Million square foot (SF) facility including janitorial, landscaping, utilities, outside contractor services, capital project work, equipment and building maintenance work, quality, loss prevention and security

Led facilities organization for 3 sites (~50 direct/indirect and 30 contract employees)

Capital Project and Construction Project Manager – all projects were delivered on time and within approved budget

o $10 Million Budget - DVD Molding Area Expansion

o $30 Million Budget – 800,000 SF Warehouse Expansion & Warehouse Management System o $44 Million Budget – 1.4 Million SF leased Packaging & Distribution Space o $15 Million Budget – 265,000 SF fast track building expansion – warehouse space

Effected a 25% reduction in the facility’s overall waste disposal cost by identifying recyclable waste streams

Led Quality Group responsible for ISO9001 Certification

Daikin America, Decatur, AL May 1993 – June 2000

Japanese owned Daikin leads its industry in the development, manufacture and sale of fluoropolymers. The Decatur, AL site is its only domestic manufacturing plant. Construction of the facility was started and completed in 1993. The monomer plant produces TFE which is then transferred to the polymer plant and reacted into PTFE. PTFE is then finished and packaged in various forms including powder, dispersion and extruded pellets.

Maintenance Supervisor/Engineer

Supported the construction and commissioning of a continuous process monomer chemical plant, batch reaction polymer plant, DIRO water plant, and waste water treatment plant

Successfully supported the reduction of breakeven timing from budgeted 5 years to 3 years

Negotiated and executed maintenance contract for ~ 100 employee contract work force to provide all aspects of maintenance support

Facilitated problem solving teams for equipment related reliability and debottlenecking issues improvements resulting in a reduction of unscheduled equipment downtime

Collected maintenance cost data and prepared maintenance and facilities budget

Served as Project Manager for annual 2 week maintenance outage (5 Years)

Served as maintenance representative on ISO 9001/2 and ISO14001 successful implementation

Identified and implemented process improvements to reduce equipment downtime and reduce process cycle time. One example yielded a 30% increase in batch processing capacity

Oversaw the labeling of all process piping and x-ray/NDT testing of Process Safety Management (PSM) covered processes

Managed the Pressure Relief Device recertification program utilizing third party service providers

E.I. DuPont de Nemours & Co.,Louisville, KY Sept 1988–April 1993 This facility was built as part of the World War II effort to manufacture neoprene. The production, packaging, and maintenance employees were members of a collective bargaining unit.

Maintenance Supervisor / Area Engineer

Directed daily work of 15 person crew consisting of instrument, electrical, and maintenance mechanics

Provided technical support in the Neoprene polymerization and finishing plants

Education

Masters of Business Administration (MBA) Auburn University 2005 Phi Kappa Phi Honor Society

BS of Electrical Engineering (BSEE) Auburn University 1988

Eta Kappa Nu Honor Society

Certifications – Publications

IAQG Certified AS9100 AATT Training 2018

IAQG Certified AS9100:2016 Lead Auditor Training 2017

Certified Pharmaceutical Industry Professional (CPIP) 2014 International Society for Pharmaceutical Engineering (ISPE)

Author “Contract Maintenance Does it Work?” Maintenance Technology Magazine March 1999

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