Kumar Shah

** ****** ***** ****: 973-***-****

Wayne, New Jersey 07470 abgtyo@r.postjobfree.com

Cell 908-***-****

Executive Summary

Engineering, Manufacturing and Quality Assurance professional with experience in the area of cGMP

compliance. Leadership and technical engineering expertise within a pharmaceutical regulated, and

FDA Consent Decree environment. Has strong technical knowledge of Equipment Validation,

Pharmaceutical manufacturing, US and EU GMP and regulatory compliance. Experience in utility,

facility, and equipment design and operation, as well as cGMP manufacturing environments related to

process equipment and maintenance of GMP facility operations. Knowledge of lean manufacturing and

ISO Quality systems with a proven record of achieving continuous improvement in safety first, zero

defects culture.

Professional Experience

Merck and Company, 2005 Present Summit, New Jersey

Facility / Engineering Manager – Equipment Development, & Maintenance: Manage a team of engineers to lead a

risk based approach on the operation, development and continued improvement of multiple cGMP facilities,

including the 2010 ISPE Facility of the Year in Summit, NJ.

Lead a team of engineers to manage the operation of critical utilities (HVAC, R.O. WFI, USP PW,

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Nitrogen, Compressed Air, Steam) and process equipment for the cGMP OSD/NSL manufacturing,

material distribution and packaging plants through coaching, and adaptive management style.

• Plan, coordinate, and support engineering activities to maintain GMP facilities used for the manufacturing

of drug products.

• Implemented Consent Decree cGMP work plans and SOPs to meet all regulatory milestones within tight

timelines at three commercial and one clinical supply Consent Decree sites.

• Represented department and programs to external Health Authority inspectors and representatives during

inspections.

• Oversee Preventative Maintenance compliance, effectiveness and maintain the computerized maintenance

management system (CMMS) for tracking work orders, spare parts, and maintenance history of plant and

manufacturing equipments.

Manage the commissioning, execution, and completion of capital projects from $2K to $1M.

Support validation engineering group on validating / upgrading of critical utilities, process equipment,

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facility, automation and controls.

Employ Operational Excellence tools including six sigma to control costs, improve productivity reduce

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deviations / CAPA and maintain regulatory compliance.

Lead investigation of manufacturing, operational excursions and deviations. Conceive corrective /

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preventive actions with cross functional agreement with quality & manufacturing teams.

Manage internal and external audit responses and defend audit observations.

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Advocate a strong safety awareness program with active monitoring through metrics, consistent

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implementation of policies through all levels in the organization and external vendors/contractors.

Manage and train external GMP service providers, and maintain training records per SOP guidelines.

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Kumar Shah

Achievements:

Instituted the “Fast response Team”, which is fully responsible for providing immediate response for batch

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manufacturing and facility related issues on a 24/7 operation. The program has resulted in 99%

manufacturing equipment availability.

Instituted predictive preventive maintenance on process equipments and utilities to reduce future downtime

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and improve manufacturing throughput.

Developed and instituted an improved preventive maintenance program for cGMP utilities and process

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equipment which boosted PM compliance rate from 70% to 95%

Increased Right First Time rate from 68% to 90% on equipment operation, reduction of deviations, and

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short term/long term forecasting to realize goals.

Schering Plough Research Institute, 2003 – 2005 Union & Kenilworth, New Jersey

Principal Engineer, Engineering & Technical Services (Global Clinical Supply)

Managed and lead the maintenance and calibration staff by coaching, development, and communication,

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change management, delegating duties, and holding staff accountable.

Maintained facilities as well as all production equipment to ensure production activity and product quality

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can continuously be adhered to with minimal downtime.

Managed work processes and schedule maintenance and calibration support levels required to meet plant

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goals and metrics.

Coordinated the facility shutdown for preventive maintenance, breakdown & maintenance and operation

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expansion activities.

Organized, developed and reviewed PM checklists for process equipment & utility using Computerized

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Maintenance Management System (CMMS).

Ensured equipment and processes are appropriately maintained and calibrated for specified manufacturing

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activities.

Created and updated the preventive maintenance program for the facility and all equipment, assigns

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responsibility to appropriate staff, and maintain scheduled monthly maintenance checklists on all

equipment.

Maintained on time execution completion rate of over 95% of maintenance & calibration activities.

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Tyco International, 1999 2003 Clark, New Jersey

Technical Staff Manager – Manage a team of engineers and technicians to meet production, quality and safety

goals in the manufacture of optical network systems.

• Fostered a customer focused business model in the manufacture of fiber optic repeaters for the industrial

telecommunication market.

• Lead a team of 10 engineers and specialists for the investigation of manufacturing and operational

deviations. Embraced a change management process with a focus on cross functional problem solving to

create engineering solutions for complex issues.

• Lead a team for the Greenfield implementation of ISO 9001 for manufacturing processes. Successful

application lead to a 20% reduction of product rejections.

• Conducted technology transfer of fiber optic mass fusion equipment, including equipment sizing, install,

validation, commissioning, documentation and training.

Kumar Shah

Kearfott Guidance and Navigation, 1989 1998 Totowa, New Jersey

Senior Metrology Engineer / Quality Assurance Engineer – Install, validate and provide OE support for

automated testing systems. Obtained Confidential clearance for defense related work.

• Designed, validated and installed test beds for military grade navigation systems, cruise missiles and

NASA space shuttle program.

• Lead a team of 10 calibration specialists through effective coaching, emphasis on technical skills, project

management and ISO 9000 compliance.

• Ensured ISO 9000 compliance during manufacturing, validation, implementation and OE support for three

manufacturing sites through regular metrics and certification of all equipment.

• Managed internal and external (US Navy, US Air Force) audit responses. Defend audit observations by

embracing the umbrella approach to ISO 9000 QMS.

Peerless Instrument, 1988 1989 Elmhurst, New York

Quality Assurance Engineer – Apply ISO 9000 standards for the quality assurance of circuit boards and

instrumentation manufacturing.

• Lead the implementation of ISO 9000 qualification standards for the manufacture of instrumentation and

controls equipment through the use of trend analysis on batch processes.

• Investigated manufacture defects, create rejection reports and manage corrective actions from onsite and

contract manufacturing processes.

• Managed internal and external audit responses. Defend audit observations by embracing the umbrella

approach to ISO 9000 QMS.

Harris Corporation, 1985 1988 Syosset, New York

System Integration Engineer – Manage integrated hybrid test stations for the US Navy and US Air Force.

• Customer focused specification, design, development and commissioning of integrated hybrid testing

stations for military applications.

• Troubleshoot and repaired electronics modules at the component level. Identify problems, root causes and

opportunities and recommended actions to increase the efficiency and productivity within the engineering

department.

• Provided leadership and training to new hires. Align new hires with business goals and provided

colleagues with constructive feedback when applicable.

Education

Long Island University, Class of 1989, Masters of Business Administration, Finance

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Pratt Institute, Class of 1984, Bachelor of Science Electrical Engineering

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Other Skills/Activities

Management Foundations, Merck & Co., Inc. 2012

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Sigma Yellow Belt Training, Merck & Co., Inc. 2011

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Operational Engineering Team Lead for Summit, NJ Facility, ISPE Facility of the Year 2011

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Eagle Award for Safety Leadership, Schering Plough, 2008

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Management Excellence Program Award, Schering Plough, 2007

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Member of International Institute of Pharmaceutical Engineers

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Allen Bradley Automation and PLC Trained

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