Quality Assurance Engineer

MICHAEL F. SALBENBLATT

**** ******* **** ***** **** 917-***-****

Kalamazoo, Michigan 49009-7595 E-mail: *************@***.***

BACKGROUND SUMMARY

Analytical, motivated, results-oriented professional with extensive experience in project management,

staffing and time studies, plant design, technology transfer, and regulatory and quality standards in

pharmaceutical and related industries. Major strengths in process and staffing improvements,

manufacturing operations, quality assurance, validation, and operational site management. Qualified in

hiring and managing both internal and external staff and outside consultants. Extensive domestic and

international work experience, both on-site and using other communication methods. Additional skills in

oral and written communications, cost reductions, product process/manufacturing design, plant network

site reduction, problem solving, and staff training and development. A decisive, energetic individual who

has a proven track record of completing projects on time and within budget, while building strong

relationships with external and internal customers; frequently called upon to successfully mediate and

resolve disputes between internal organizations to create a “win/win” environment.

CAREER HISTORY

PFIZER, INC., New York, NY 1978–2008

World's largest research-based biomedical and pharmaceutical company. Acquired Pharmacia in 2003.

Upjohn merged with Pharmacia in 1994.

Senior Manager – Pfizer Global Engineering (Corporate Headquarters, NYC & NJ) (2003–2008)

Together with site management developed their annual capital project, engineering, and maintenance

budgets; and analyzed their monthly reports to ensure compliance and success.

Coordinated site’s global energy footprint reduction program to ensure goal was achieved.

Participated in value management sessions resulting in optimization of project schedule and cost.

Used value engineering to redefine project scope, resulting in a reduction of time and capital.

Managed a major third-party manufacturing project involving multiple internal and external

teams, resulting in significant capital reduction while maintaining project's scope and schedule.

Leveraged expertise in engineering, manufacturing and quality operations to provide consulting

services across major capital projects, achieving consensus and effectiveness.

Assisted as validation consultant on large project, completing it two months earlier than

scheduled.

Facilitated site programs for Energy, Reliability Maintenance, and Green Building programs.

Executed validation activities of HVAC systems in a new aseptic (sterile) processing facility in

Kalamazoo, MI, delivering each system under budget and ahead of schedule.

Senior Mgr. Validation, Pharmacia Global Engineering Technology, Kalamazoo, MI (2001–2003)

Managed internal and external staffs in numerous program developments and specific project executions.

Wrote and edited corporate guidelines on facility, equipment and utility validation for all projects

over $5 million, substantially reducing validation costs by using a risk-based approach.

Created documentation and templates further reducing program’s documentation cost, and

performed training at all sites worldwide, improving productivity and morale.

Developed a database allowing sites to leverage work performed by others, resulting in a

considerable reduction of validation time and cost for all new projects, generating savings of 20%

to 25% per project.

cGMP Computer Validation Consultant, Corp. Quality Assurance, Kalamazoo, MI (2000–2001)

Participated in the design, development, training, and auditing of the corporate cGMP computer

validation program, including 21 CFR Part 11 compliance; to create and provide an effective, efficient

and consistent corporate program.

MICHAEL F. SALBENBLATT page 2

Quality Manager, Corporate Quality Assurance, Kalamazoo, MI (1996–2000)

Performed internal and external site quality audits to ensure compliance with corporate and regulatory

standards.

Participated in revising corporate quality standards and guidelines, creating a tiered approach

based on a site’s business and regulatory needs, resulting in a substantial cost reduction.

Reviewed currently practiced and expected basic quality standards in plant design and operation,

ensuring FDA compliance.

Senior Industrial Engineering, Technical Support Operations/Mfg, Kalamazoo, MI (1993–1996)

Provided technical and engineering assistance to manufacturing and support functions to increase their

efficiency and reduce manufacturing cost; including staffing and scheduling studies.

International Industrial Engineering Manager, Kalamazoo, MI (1984–1993)

Developed and implemented a production standard and cost system (man and machine) used worldwide

and coordinated sharing of productive results between sites. Facilitated standardization and sharing of

cost-reduction manufacturing methods worldwide.

Performed initial plant rationalization study resulting in a 20% reduction to the number of sites

worldwide, improving profitability.

Project Engineer and Manager for design, construction and start-up of pharmaceutical packaging

plant in USSR. Project teams in three countries and were on time and 10% under budget.

Industrial Engineer, Kalamazoo, MI, Operations (1978–1984)

Supported plant operations in Kalamazoo and Puerto Rico, ensuring productive and cost-effective

operations.

Team Leader in the design of two new green site facilities which were state-of-the-industry

operations; exceeded expectations for delivered due date, budget and production performance.

BRONSON METHODIST HOSPITAL, Kalamazoo, MI, 1975–1978

Flagship of Bronson Healthcare Group, a non-for-profit provider in southwest Michigan & northern

Indiana.

Industrial/Management Engineer - System Development Unit

Performed various staffing, productivity, and scheduling studies to reduce manpower costs and better

schedule operations with known fixed and variable costs.

KAL-EQUIP, Otsego, MI 1974–1975

Private developer and manufacturer of automotive testing and tune-up equipment.

Industrial Engineer, Packaging and New Products Work Flow Analysis

EDUCATION AND PROFESSIONAL DEVELOPMENT

M.S., Industrial Engineering/Operation Research, Western Michigan University, Kalamazoo, MI

B.S., Manufacturing Engineering, Western Michigan University, Kalamazoo, MI

OSHA 10 Hour Certification

Quality Risk Management (QM) Training

Effective In House Consulting, and Problem Analysis and Decision Making

Capital Project Management Process (CPMP)

Purdue Basic Pharmaceutical Course, Purdue University, Lafayette, IN

Spanish language classes

PROFESSIONAL AFFILIATIONS

Member of International Society of Pharmaceutical Engineers

Member of International Industrial Engineering

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