Robert Berkley Campbell - Industrial Engineer

Address: ** *. ********* ***., ********, NY 11714

Contact by email: acb6sk@r.postjobfree.com

Contact by phone: 631-***-****

Objective

. Incorporate my passion and expert knowledge in industrial engineering

and continuous process improvement in support of a lean manufacturing

environment.

Work Experience

Contract Pharmacal Corporation (CPC)

October, 2011 - December, 2013

135 Adams Avenue

Hauppauge, NY 11788

. Process & Packaging Validation Engineer; Technical Services Department

. Expert knowledge in the manufacturing and packaging processes of "over-

the-counter" drug products and dietary supplements, and the FDA

regulations therein

. Managed and supervised a multitude of validation projects, i.e.

Prospective and Concurrent Process Qualifications and Verifications,

Packaging Validations and Engineering Studies, Cleaning Validations,

Product Challenge Studies, Process Optimization Studies, Bulk Hold

Time Studies, and Gap Remediation projects as required

. Validation Engineering duties included, but were not limited to,

authoring and executing validation protocols, training and managing

personnel, investigating deviations and implementing root cause

analysis, initiating and overseeing change control and CAPA system,

analyzing data with statistical analysis techniques (Process

Capability and Analysis of Variance), and authoring and approving

final reports

. Provided recommendations and updates to upper management within

Quality Assurance, Manufacturing, Packaging and Quality Control

departments

. Part of the validation team which implemented a successful

Validation Program in compliance with current industry standards and

regulations (e.g. cGMP) which lead to the lifting of an FDA warning

letter

Work Experience, Continued

Contract Pharmacal Corporation (CPC)

December, 2013

160 Commerce Drive

Hauppauge, NY 11788

. Compliance Engineer; Manufacturing Department

. Enforced adherence to Standard Operating Procedures, current Good

Manufacturing Practices and Good Documentation Practices within

manufacturing department

. Conducted deviation investigations and implement root cause analysis

in response to Complaints, Change Controls, Out-of-Specification

results and Low Production Yields

. Developed CAPA to improve process controls and eliminate human error

during manufacturing operations

. Instituted a "first-time-right" attitude for batch record

documentation and other metrics

. Authored Annual Quality Reviews for over-the-counter, validated bulk

and packaged product

Educational Background

Binghamton University, State University of New York

August, 2005 - August, 2011

Thomas J. Watson School of Engineering and Applied Science

PO Box 6000, Binghamton, New York 13902

. Masters of Science Degree, concentration in Industrial and Systems

Engineering, August 2011

. Bachelors of Science Degree, concentration in Industrial and Systems

Engineering, May 2009

. Overall GPA: 3.77; Major GPA: 3.80 (Aug '05 - August '11)

. Graduated Magna Cum Laude & Engineer-In-Training (Fundamentals of

Engineering Certification)

. President of Institute of Industrial Engineers (IIE) & Industrial

Engineering Honor Society Skills

. Personal: Self starter, Ability to multi-task, Goal-oriented, Team

player, Detail-oriented, Well-organized

. Professional: Manufacturing/Supply Chain, Process Optimization,

Industrial Engineering, Quality Assurance, FDA Compliance, Continuous

Process Improvement

. Computer: Microsoft Word, PowerPoint, Excel, Visio, Project; Alphalan,

Minitab, AutoCAD, MatLab and Arena.

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