Validation Engineer - Prisym Labeling
Company Name:
USDM
The validation engineer is a corporate resource that is to be deployed to manufacturing sites for the execution of printer and manufacturing line validations. The validation engineer will work directly with the UDI Engineering team in the development of validation documentation, and execution of equipment validations.
Essential Functions:
o Works as part of a cross-functional team that is rolling out new labeling standards across the company
o Knowledge of UDI, GS1, AIDC preferred
o Execution of protocols for packaging equipment (labeling, inkjet, thermal transfer)
o Experienced in validation execution (IQ, OQ, PQ)
o Works directly the manufacturing plants on integrating Corporate protocols into site quality systems
o Hands-on, execution of validation protocols and write summary reports
o Technical support for production labeling systems implementation (Prisym, custom Print on Demand)
o 8Works directly with the manufacturing plants on the implementation of Prisym at identified plants
ESSENTIAL ABILITIES:
o Motivational and interpersonal skills
o Must embrace change and work within a changing environment.
o Must possess strong analytical skills to evaluate complex technical information
o Detail oriented with the ability to prioritize and meet deadlines in a fast-paced environment
o Ability to perform research and data-gathering assignments with little direct supervision
o Ability to interpret complex instructions and procedures
o Superb time management and organizational skills
o High tolerance for ambiguity
EDUCATION:
o BA/BS Degree (management/engineering/packaging) required.
Experience:
o Manufacturing validation experience (IQ/OQ/PQ) required.
o Relevant experience of working in project teams in one of the key project related functions (Research, Product Development, Regulatory Affairs, Production, Operations, Quality Assurance, Marketing).
o Experience in Medical Device industry and/or with packaging, labeling, and printing technologies preferred.
o Strong project management skills required - ability to organize and manage multiple priorities.
o
Preferred Skills /
Qualifications:
o Six Sigma and/or Lean certification preferred
o PMP certification a plus
o Microsoft Office (Word, Excel, Outlook, PowerPoint, Project, etc.)
o Label software application experience a plus
o
Communication:
o Ability to communicate effectively in multi-discipline environment, and across cultures and levels of organization. Must possess excellent interpersonal, written and oral communication skills, with demonstrated ability to communicate both technical and business information.
CORE COMPETENCIES:
o Action Oriented
o Dealing with ambiguity
o Integrity and Trust
o Functional/Technical Skills
o Managing and Measuring Work
o Learning on the Fly
o Technical Learning
o Written Communications
WORKING CONDITIONS:
o Onsite
o Schedule takes the project through September 2015
o Nominal travel 50%
For immediate consideration, email your resume to me atEstimated Salary: $20 to $28 per hour based on qualifications.
USDM
The validation engineer is a corporate resource that is to be deployed to manufacturing sites for the execution of printer and manufacturing line validations. The validation engineer will work directly with the UDI Engineering team in the development of validation documentation, and execution of equipment validations.
Essential Functions:
o Works as part of a cross-functional team that is rolling out new labeling standards across the company
o Knowledge of UDI, GS1, AIDC preferred
o Execution of protocols for packaging equipment (labeling, inkjet, thermal transfer)
o Experienced in validation execution (IQ, OQ, PQ)
o Works directly the manufacturing plants on integrating Corporate protocols into site quality systems
o Hands-on, execution of validation protocols and write summary reports
o Technical support for production labeling systems implementation (Prisym, custom Print on Demand)
o 8Works directly with the manufacturing plants on the implementation of Prisym at identified plants
ESSENTIAL ABILITIES:
o Motivational and interpersonal skills
o Must embrace change and work within a changing environment.
o Must possess strong analytical skills to evaluate complex technical information
o Detail oriented with the ability to prioritize and meet deadlines in a fast-paced environment
o Ability to perform research and data-gathering assignments with little direct supervision
o Ability to interpret complex instructions and procedures
o Superb time management and organizational skills
o High tolerance for ambiguity
EDUCATION:
o BA/BS Degree (management/engineering/packaging) required.
Experience:
o Manufacturing validation experience (IQ/OQ/PQ) required.
o Relevant experience of working in project teams in one of the key project related functions (Research, Product Development, Regulatory Affairs, Production, Operations, Quality Assurance, Marketing).
o Experience in Medical Device industry and/or with packaging, labeling, and printing technologies preferred.
o Strong project management skills required - ability to organize and manage multiple priorities.
o
Preferred Skills /
Qualifications:
o Six Sigma and/or Lean certification preferred
o PMP certification a plus
o Microsoft Office (Word, Excel, Outlook, PowerPoint, Project, etc.)
o Label software application experience a plus
o
Communication:
o Ability to communicate effectively in multi-discipline environment, and across cultures and levels of organization. Must possess excellent interpersonal, written and oral communication skills, with demonstrated ability to communicate both technical and business information.
CORE COMPETENCIES:
o Action Oriented
o Dealing with ambiguity
o Integrity and Trust
o Functional/Technical Skills
o Managing and Measuring Work
o Learning on the Fly
o Technical Learning
o Written Communications
WORKING CONDITIONS:
o Onsite
o Schedule takes the project through September 2015
o Nominal travel 50%
For immediate consideration, email your resume to me atEstimated Salary: $20 to $28 per hour based on qualifications.
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