Engineer Customer Service

COLLEEN GORMAN MALCOLM

Columbus, OH *****, cell: 614-***-****,

**********@*****.***

SUMMARY

. Hands-on Green Belt Certified professional with diverse experience in

risk-based compliance environments, pharmaceutical manufacturing and

packaging, and specialty chemical manufacturing.

. Knowledge and experience working with regulatory standards and process

requirements including GMP (Good Manufacturing Practices).

. Proficient in computer skills including SAP and Microsoft Office (Word,

Excel, Outlook, Power Point).

. Background includes completing projects using Lean Sigma DMAIC (Define,

Measure, Analyze, Improve, and Control) process to determine root cause

and corrective actions, executing risk assessment events, and performing

process audits to maintain ISO/TS 16949 certification.

. Experience preparing investigational compliance documentation for failure

analysis of deviations in the pharmaceutical industry. Customers included

internal quality assurance engineers, internal auditors, and FDA.

. Proven effectiveness in using lean manufacturing and Green Belt Six Sigma

tools, managing projects, introducing new products, and performing data

analysis using statistics.

. Successful track record in a variety of environments including

laboratory, pilot plant, and production scale settings.

. Excellent communication and interpersonal skills.

PROFESSIONAL EXPERIENCE

PERRIGO COMPANY, Allegan, Michigan 2006 to October 2009

World's largest manufacturer of over-the-counter pharmaceutical products

for the store brand market

Continuous Improvement Engineer

. Achieved annual savings of $250K by determining root cause and completing

corrective actions that resulted in eliminating laboratory failures

caused by dispensing failures and mistake-proofing the dispensing

production scales.

. Prevented stability failures for a specific packaging line through

determining root cause and corrective action. Developed and executed

test protocol for confirmation testing after the completion of the

equipment's program change.

. Guided small teams using the Lean Sigma DMAIC process and updating

procedures for determining product yield, which resulted in contributing

to meeting the Right First Time goal of 99%.

. Eliminated laboratory failures for three packaging lines' beginning of

batch samples with a cost savings of $100K through determining root cause

and completing corrective actions.

ASHLAND INC., Calumet City, Illinois 2003 to 2006

Specialty chemical company providing innovative products; formerly Ashland

Chemical Company

Process Engineer II

. Led small teams through three Process Hazard Analysis (PHA) events and

supported four other PHA teams, using hazards identification and risk

analysis methodologies to meet Process Safety Management requirements in

less than two years.

. Represented Calumet City production plant to the Ashland corporate office

through coordinating and leading business line steering team meetings and

presenting manufacturing updates at corporate quarterly business meetings

to senior management.

. Served as primary interface between manufacturing and product

development/ technical service personnel while transferring and

implementing the new product knowledge from pilot to production scale.

Received Ashland Beacon Award for introducing five new products with a

forecast of $400,000 in annual sales within customer's one-month

timeframe.

. Achieved annual savings of $50,000 by increasing yield and decreasing

cycle times for products using Six Sigma tools. Trouble-shot existing

products to meet product specifications.

BATTELLE MEMORIAL INSTITUTE, Columbus, Ohio 2000 to 2003

Non-profit global science and technology enterprise that develops and

commercializes technology

Researcher for the Process Engineering Group

. Contributed to Biotechnology Process Development & current Good

Manufacturing Practices Process team's successful vaccine development

work. Performed hands-on protein purification pilot plant tasks,

including High Performance Liquid Chromatography and Ultra-Violet

Spectrophotometry. Maintained current Good Manufacturing Practices

documentation.

. Led team in hands-on laboratory activities using statistical methodology

including design of experiments and project management tools to meet

clients' deliverable and solution more quickly for pollution prevention

programs.

. Audited client's facilities for air emission sources. Constructed air

emissions history summary by calculating potential and actual air

emissions changes over time as a member of Prevention of Significant

Deterioration assessment team.

TRUTEC INDUSTRIES, Springfield, Ohio 1998 to 2000

Heat treatment facility which serves automotive industry through quality,

service, and technical support

Process Engineer

. Reduced labor and overall costs by facilitating testing to eliminate

process step and optimize process.

EDUCATION & PROFESSIONAL DEVELOPMENT

. Bachelors of Science in Chemical Engineering, University of Dayton,

Dayton, Ohio, 1998

. Co-op Process Engineer at Tate and Lyle (formerly Haarmann & Reimer) in

Dayton, Ohio for 3 semesters, 1995 to 1997

. Environmental Summer Intern at Rohm and Haas in Louisville, Kentucky,

1995

. Deans Engineering Scholarship

. Engineer In Training (EIT) Certification

. Completed formal training in statistics, Root Cause Analysis Methodology,

Technical Writing, Perrigo Auditing Safety System training, DISC

(Dominance Influence Steadiness Conscientiousness), Influencing Results

without Authority, leading hazards identification and risk analysis

methodologies, Green Belt Lean Six Sigma, process mapping, ISO/ TS 16949

Auditing, Project Management, Microsoft Project, Microsoft Visio,

Minitab, Microsoft Access, SAP, Presentation Skills, Customer Service, &

Conflict Management.

. Participated in the Perrigo Supervisor Development Program and Perrigo

Exempt Networking Program.

. Completed classes at Franklin University's Center for Professional

Training and Development including Quality Management, Time Management,

The Customer Driven Organization, and Selling Professional Services, 2009

and 2010

PROFESSIONAL & COMMUNITY AFFILIATIONS

. American Institute of Chemical Engineering (AIChE) Society Member, 1993-

2003

. Elected Vice President for AIChE Society for Columbus, Ohio Local

Chapter, 2003

. Leukemia & Lymphoma Society's Team in Training Runner & Fundraiser, 2005-

2007

. Leukemia & Lymphoma Society's Team in Training Mentor, 2007

. Make a Difference Day Volunteer, 2009

. Team Battelle Participant for United Way's Community Care Day, Shadow

Program for Youth Interested in Science, Race for the Cure, and Godman

Guild, 2000-2003

. Third Grade teacher for Junior Achievement & other extracurricular

activities, 1998-2000, 2003-2005

. Tuesday Tuneup Networking Group Co-Facilitator and Volunteer, 2010

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