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Manufacturing Engineer - 53287434 - SB

Job Code: 53287434
Job Location: Monmouth Junction, NJ
Category: Manufacturing Engineer
Last Updated: 09/19/2016
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Job Description:
Responsible for performing and overseeing the validation of manufacturing processes, facility, equipment, system and cleaning processes. Evaluate impact of proposed changes to utilities, equipment and processes on the validated state and also support day to day manufacturing activities to meet the market demand. Experience with and understanding of regulatory agencies (FDA (Food and Drug Administration), ISO (International Standard Organization) etc.  
• Develop and coordinate execution of protocols for equipment and process validations, prepare final reports following the execution.
• Responsible for evaluation and analysis of data, lead investigation and documentation of all validation activities
• Assist in the implementation and maintenance of the Master validation Plan.
• Participate in product and process development and design transfer activities to ensure launch goals are achieved.
• Provide support for pFMEA (Process Failure Mode Effect Analysis), CAPA (Corrective Action and Preventive Action), and QN’s (Quality Non-conformance) efforts as assigned. Initiates investigations of problems and deficiencies to ensure a high level of product quality.
• Establish the metrics and monitor the performance of processes, equipment, and tools to verify their efficiency, and process improvement as needed.
• Act as technical resource, where needed, to help with the design, development, evaluation, or troubleshooting of manufacturing processes, testing procedures and/or other systems.
• Provide technical support to Manufacturing, Strategic Procurement, and Suppliers by interpreting product requirements and resolving technical production problems.
• Work with, but not limited to, Research and Development, Marketing, Quality, Regulatory Affairs, Material Planning, Distribution, Strategic Procurement, Manufacturing facilities and suppliers to provide or secure information, coordinate activities and solve problems.
• Assist in the prevention and resolution of technical production and validation issues with assigned products by working with manufacturing engineering, operations and quality personnel.
Minimum Education and Experience -
Bachelor’s degree in Mechanical or Industrial Engineering with minimum of 10 years of related experience in Medical device or Pharma.
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 53287434SB
Equal Opportunity Employer


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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