Project Manager Engineer

Kyle R. Scott

**** *. * ****** • Kalamazoo, MI **048 • 269-***-**** • ****@*******.***

OBJECTIVE: Project Manager in the pharmaceutical industry.

PROFILE Highly motivated, positive, and achievement-oriented leader with 5 years of experience in the biotech and pharmaceutical

industry with applied knowledge in an FDA / EU compliant manufacturing environment and cGMP / cGLP pharma

industry, 3 years of which were direct project management experience and FDA / EU compliant experience including

Pharma Toll and product transfer. Performs all job duties and responsibilities in a compliant and ethical manner and in

accordance with all applicable healthcare laws, regulations, and industry codes. Continuous improvement mindset lends

to improving new technologies and processes, obtaining and maintaining certifications, and encouraging colleagues.

Creative problem-solving and management skills have been provided to clients including Boehringer-Ingelheim

Vetmedica, Inc., Perrigo, ConAgra, Kellogg, Mead Johnson Nutrition Company, and Royal DSM Company thus far.

SKILLS Leadership Process Validation Facility Operations Budgeting

Project Management WebEx Change Control Lean Six Sigma Methodology

Construction Management SharePoint Powder Handling / Processing

Microsoft Office & Softwares TrackWise Food & Pharmaceutical Packaging

InforEAM cGLP Toll Processor Operations

Process Optimization FDA GMP Toll Pharmaceuticals

WORK EXPERIENCE

CSM group Kalamazoo, MI March 2014-

Project Manager Present

Full-time consulting position managing client capital projects, overseeing the installation and set-up of equipment,

qualifying and validating the installation of production suites, packaging lines, and general facility installs for clients

including Perrigo, ConAgra, Kellogg, and Boehringer-Ingelheim Vetmedica, Inc.

Worked with team to install / qualify new scale-up process equipment for product being transferred to Perrigo

Holland, MI site

Successfully completed over 60 large and small projects within budget in the past year

Created Preventative Maintenance schedules, TrackWise cases (Change Control), or wrote Manual Change

Control cases for all projects

Assigned to lead and manage a $50K laboratory renovation project for Boehringer-Ingelheim Vetmedica, Inc.

Aided in design of prototype mixer for Bactrians bio vessels to replace non-cGMP compliant cable stir style

mixers for Boehringer-Ingelheim Vetmedica, Inc.

Received 100% satisfaction in client survey from Perrigo

CRB Consulting Engineers – Kalamazoo, MI November 2012 –

Process Engineer March 2014

Full-time position fulfilling consulting duties by providing engineering support to clients including Perrigo, Royal DSM

Company, and Mead Johnson Nutrition Company.

Coordinated closely with engineering, manufacturing, facilities, process technology, QA, QC, validation, and

regulatory affairs on project teams to facilitate design, transfer, and startup of manufacturing process changes

Upgraded blending suites by installing and qualifying GMP-compliant screening equipment along with new

technologies to optimize the blending process

Examined risk associated with all PMH HVAC system filters regarding fire prevention and determined corrective

actions for each unit, implemented upgrades, and organized system filter data

Attended FATs on behalf of Perrigo for new process equipment

Led training of new process equipment for Perrigo employees

Nitrate Elimination Company, Inc. (NECi) – Lake Linden, MI January 2010 –

Biochemist September 2012

Full-time position performing research and development, conducting experiments, and providing technical project

assistance.

Performed research and development of enzymes for use in agricultural setting

Administered SOP troubleshooting and development

Developed and maintained an organized record-keeping system and prepared detailed lab reports

Trained new employees in cGLP and entry-level tasks

Presented research at Michigan Green Chemistry Conference in Detroit, MI on October 18, 2012

EDUCATION Michigan Technological University August 31, 2012 CERTIFICATIONS OSHA 30 Hour

B.S. Pharmaceutical Chemistry CPR / First Aid

LEED AP BD+C

Undergraduate Research August 31, 2012 Lean Six Sigma Yellow Belt

USDA Funded Grant

Contact this candidate