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Sr. Project Engineer

In Puerto Rico / United States

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Sr. Project Engineer   

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JOB TITLE:
Sr. Project Engineer
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Caguas Puerto Rico / United States

JOB DESCRIPTION :
Sr. Project Engineer
Pay Rate: $39/HR


Cortech is seeking a Sr Project Engineer.


Job Description:
? Responsible for the development and execution of validation & remediation projects as part of divisional strategies
? Performance of validation gap assessment & analysis, validation master plans, and validation protocols (generation/execution/reports) such as IQ/OQ/PQ/PPQ/Decommissioning for existent and new products.
? Performance of different kinds of validations, such as process & equipment validations, software validation, test method, and inspection method validations.
? Performance of confirmation runs and product build ups at manufacturing as part of divisional projects requirements.
? Continuous interaction with divisional project leaders to support their activities at site level

Experience
? 7-10 years in Engineering field (mechanic, electrical or chemical)
? Experience in Medical Devices Industry
? Knowledge in current quality regulations and cGMPs (FDA/EU MDR and others)
? Strong experience in qualification activities (IQ OQ PQ PPQ TMV IMV) documentation generation/execution/closing for existent and new product introduction
? Experience managing projects – planning/organization/presentations
? Technical writing experience (in English)
? Flexibility to work on weekends as required
? Experience working with MS Office programs (Word, Excel, Project, Power Point)
? Strongly fluent in English. This person will interact with US resources 80% of the time
? Presentation skills experience

Position Details

Jun 12, 2021
Information Technology (IT)
S16204860700073120
Puerto Rico / United States
Caguas
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Sr. Project Engineer    Apply

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Sr. Project Engineer
Pay Rate: $39/HR


Cortech is seeking a Sr Project Engineer.


Job Description:
? Responsible for the development and execution of validation & remediation projects as part of divisional strategies
? Performance of validation gap assessment & analysis, validation master plans, and validation protocols (generation/execution/reports) such as IQ/OQ/PQ/PPQ/Decommissioning for existent and new products.
? Performance of different kinds of validations, such as process & equipment validations, software validation, test method, and inspection method validations.
? Performance of confirmation runs and product build ups at manufacturing as part of divisional projects requirements.
? Continuous interaction with divisional project leaders to support their activities at site level

Experience
? 7-10 years in Engineering field (mechanic, electrical or chemical)
? Experience in Medical Devices Industry
? Knowledge in current quality regulations and cGMPs (FDA/EU MDR and others)
? Strong experience in qualification activities (IQ OQ PQ PPQ TMV IMV) documentation generation/execution/closing for existent and new product introduction
? Experience managing projects – planning/organization/presentations
? Technical writing experience (in English)
? Flexibility to work on weekends as required
? Experience working with MS Office programs (Word, Excel, Project, Power Point)
? Strongly fluent in English. This person will interact with US resources 80% of the time
? Presentation skills experience