Manager Resume Kankakee, IL - Hire IT People

SUMMARY

Mechanical Engineer offering “hands - on” processing and management experience within pharmaceutical operations in an FDA regulated environment.
Leading and supervising teams responsible for driving improvements.
Successful in using a solid foundation of manufacturing and quality disciplines to solve problems in a fast paced and ever changing environment.

Areas of Expertise

Knowledge of DCMS, TrackWise, SAP, Athena and MSOffice programs
Experience in change control, risk assessment and IQ/OQ/PQ of new and existing equipment
Experience working with fully automated, high speed filling, inspection, and packaging lines as well as semi-automated mechanical lines
Experience with product serialization
OSHA training and certification
Experience working with hydraulics/pneumatics
Experience supervising 100+ union Production Operators
Experience developing and maintaining a production schedule
Experience writing and revising SOP’s (Standard Operating Procedures)
Working knowledge of cGMP’s, CFR’s, change control

PROFESSIONAL EXPERIENCE

Confidential, Kankakee, IL

Manager

Responsibilities:

Manage 75 union/hourly, 9 company/salary personnel
Support deviation investigations
Develop and implement CAPAs
Develop and maintain yearly budget
PCS board/lean/5s implementation to department
Developed justification for multi-million dollar expansion project to meet production demands
Develop employee performance objectives
Ensure quality products are released to consumers
Develop, empower, mentor direct reports

Confidential, Kankakee, IL

Process Engineer

Responsibilities:

Provide front line engineering support for equipment in 3 aseptic filling areas and an isolator vial filling line
Handle project technical lead duties on multiple projects dealing with equipment, facility upgrades and repairs
Have experience troubleshooting autoclaves, depyrogenation tunnels, time/pressure filling vessels, sterile filtration setups, load/weighing cells, print/inspection equipment
Lean team leader experience for breakdown reduction and minor stops
Have implemented process changes to eliminate a number of production stoppages resulting in an increase in yields and a major decrease in downtimes
Have implemented modifications to equipment to eliminate variability in the setup process between operators

Confidential, Kankakee, IL

Lead Production Supervisor/Project Engineer/Process Engineer

Responsibilities:

Manufacturing technical lead on serialization implementation team for automated packaging line
In charge of 5-8 supervisors and 70-100 union production crew within a pharmaceutical manufacturer
In charge of production scheduling and achieved 99% on-time deliveries with minimal overtime
In charge of departmental safety, including but not limited to job safety analysis, monthly audits and operator communications
Involved in numerous risk assessments, optimizing equipment and writing/modifying current Standard Operating Procedures(SOP's) as well as SOP's for new equipment
Handle day to day communications between departments and outside contractors
Hands-on experience working with high-speed “state-of-the-art”, 100% automated equipment manufactured in Italy, Germany and the United States
In charge of maintaining accurate documents required by the FDA and other international health organizations
Experience with (HMI’s) Human-Machine-Interfaces
Ability to learn/train employees on new equipment, problem solve and troubleshoot equipment thereforeeliminating the need for vendor support which reduces costs
Installed a semi-automated inspection line and qualified an automated packaging line. As well as separating the inspection and packaging equipment into two separate processes
Worked as a process engineer on an automated, high speed syringe packaging line handling communications with vendors and optimization of individual machines that make up the system
Coordinate work being performed by maintenance and manufacturing to complete projects by their given deadlines
Have a working knowledge of cGMP’s, SOP’s, DCMS, Athena, SAP, GDRS, Trackwise and Plateau

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Manager Resume

Kankakee, IL

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