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Scott Hamm

Validation Coordinator @ Mallinckrodt

US Director of CQV and Compliance Services at Jacobs

Greater Indianapolis

Ranked #184 out of 3,683 for Validation Coordinator in Indiana

Section title

Scott Hamm's Email Addresses & Phone Numbers

Scott Hamm's Work Experience

Mallinckrodt

Validation Coordinator

January 1994 to January 1999

Indianapolis, Indiana Area

General Electric

Systems Test Engineer

January 1989 to October 1990

Syracuse, New York Area

Jacobs

US Director of CQV and Compliance Services

Indianapolis, Indiana Area

Scott Hamm's Education

Purdue University

BS, Electrical Engineering

1984 to 1988

Scott Hamm's Professional Skills Radar Chart

Based on our findings, Scott Hamm is ...

Strong sense of self
Matter-of-fact
Deep

What's on Scott Hamm's mind?

Based on our findings, Scott Hamm is ...

56% Left Brained
44% Right Brained

Scott Hamm's Estimated Salary Range

About Scott Hamm's Current Company

Mallinckrodt

Senior Manufacturing Engineer responsible for validation of all processes involved in the manufacture of liquid oxygen systems to ensure compliance with GMP and ISO-9000 requirements. Developed validation procedures, validation master plan/schedule, process control plans, and validation templates. Trained employees and managed validation team to validate all mfg processes. Coordinated revalidation efforts based on plant layout reconfigurations. Provided...

Frequently Asked Questions about Scott Hamm

What company does Scott Hamm work for?

Scott Hamm works for Mallinckrodt


What is Scott Hamm's role at Mallinckrodt?

Scott Hamm is Validation Coordinator


What is Scott Hamm's personal email address?

Scott Hamm's personal email address is m****[email protected]


What is Scott Hamm's business email address?

Scott Hamm's business email addresses are not available


What is Scott Hamm's Phone Number?

Scott Hamm's phone (317) ***-*586


What industry does Scott Hamm work in?

Scott Hamm works in the Pharmaceuticals industry.


About Scott Hamm

📖 Summary

Validation Coordinator @ Mallinckrodt Senior Manufacturing Engineer responsible for validation of all processes involved in the manufacture of liquid oxygen systems to ensure compliance with GMP and ISO-9000 requirements. Developed validation procedures, validation master plan/schedule, process control plans, and validation templates. Trained employees and managed validation team to validate all mfg processes. Coordinated revalidation efforts based on plant layout reconfigurations. Provided process validation consulting to corporation. Implemented cost reduction project resulting in $250K/yr savings. Implemented semi-automated welding systems resulting in a $400K/yr. savings Implemented conveyorized cleaning system resulting in $60K/yr savings. Utilized DOE, FMEA, QFD, process capability techniques to define process/product specifications. Utilized control charts/SPC techniques to define/monitor mfg processes. Resolved day to day production problems involving mfg processes. From January 1994 to January 1999 (5 years 1 month) Indianapolis, Indiana AreaSystems Test Engineer @ General Electric Systems Test Engineer for GE Aerospace, responsible for simulation testing of anti-submarine warfare hardware and software. From January 1989 to October 1990 (1 year 10 months) Syracuse, New York AreaUS Director of CQV and Compliance Services @ Jacobs Providing commissioning, qualification and validation expertise and leadership for Jacobs. Responsible for growing the Jacobs CQV program in our quest to become a leading CQV service provider in the life sciences industry. Indianapolis, Indiana AreaCapital Project Manager @ Eli Lilly and Company Responsible for managing $80MM renovation project for a new commercialization launch facility, consisting of a new liquid vial filling operation, a new pre-filled syringe filling operation and a new pre-filled syringe inspection line. Primary responsibilities include managing budget, schedule and resources. From January 2011 to December 2012 (2 years) Indianapolis, Indiana AreaValidation Coordinator @ Roche Diagnostics Senior Manufacturing Engineer responsible for validation of process equipment used to manufacture and package diabetic test strips. Responsible for developing process FMEA's, control plans, operating procedures, PM procedures, vendor acceptance test documentation, and validation protocols for all new equipment utilized to manufacture and package diabetic test strips. These responsibilities contributed to the success of an expansion project, which increased production capacity by 75%. From January 2000 to March 2002 (2 years 3 months) Indianapolis, Indiana AreaBioVoke Product Manager @ Commissioning Agents, Inc. Product Manager for BioVoke, a cloud-based enterprise software solution designed to manage GMP information and deliver projects more efficiently, which allows clients to deliver products to market in an expedient and compliant manner. For more information, please visit www.biovoke.com.. From September 2014 to January 2017 (2 years 5 months) Indianapolis, Indiana AreaCommissioning and Qualification Manager @ Eli Lilly and Company Responsible for managing the Global Facilities Delivery department that provides commissioning & qualification and maintenance package development support and expertise to capital projects worldwide. From January 2012 to August 2014 (2 years 8 months) Indianapolis, Indiana AreaCommissioning & Qualification Project Manager @ Eli Lilly and Company Responsible for managing the commissioning and qualification aspect of capital projects globally. Most recent projects include a new prefilled syringe filling operation, a new liquid vial filling operation, and a new powder vial filling operation in Indianapolis, all of which were completed on schedule and under budget. Also developed the C&Q strategy for the delivery of a packaging/warehouse facility in Suzhou, China. Was instrumental in the development of Global Quality and Engineering Standards governing asset delivery. Have developed several SOPs and guidance documents defining commissioning and qualification requirements for capital projects (e.g., User Requirements, FAT, Receipt Verification, Installation Verification, Design Qualification, IQ, OQ, Discrepancy Management, Boundary Determination, etc.). Have trained Eli Lilly personnel on commissioning & qualification program requirements. Regularly hire and manage contractors to perform commissioning & qualification activities for large capital projects. From September 2002 to December 2010 (8 years 4 months) IndianapolisC&Q Engineer @ Performance Solutions, Inc C&Q Engineer responsible for providing C&Q contract support to pharmaceutical manufacturing companies. From January 1991 to January 1994 (3 years 1 month) Indianapolis, Indiana Area


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In a nutshell

Scott Hamm's Personality Type

Introversion (I), Intuition (N), Thinking (T), Judging (J)

Average Tenure

3 year(s), 5 month(s)

Scott Hamm's Willingness to Change Jobs

Unlikely

Likely

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