Validation Engineer - non CA 8/22/2020
JOB DESCRIPTIONAPPLY Our client is looking for a VALIDATION ENGINEER located in SUMMIT, NJ. The Validation Engineer supports the successful implementation of equipment/utilities/facility/lab instruments at multi-use sites through interaction with internal customers and external service providers.
* The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity.
* With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope.
* Maintains qualified equipment systems in compliance with policies, guidelines and procedures
* Develops qualification protocols, and associated reports while adhering to a change management process.
* Supports the execution of equipment qualifications and validation protocols
* Supports equipment qualification and validation activities including Controlled Temperature Units (CTU) temperature mapping.
* Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
* Provides technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met. c. Provides technical support and guidance on equipment and computer systems qualification and validations issues.
* BS in Engineering or Science related discipline preferred
* Minimum of 4 years experience performing/supporting activities in a GMP environment
* Proficient in CTU temperature mapping
* Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
* Experience in the qualification of cell therapy equipment a plus.
* Knowledge of pharmaceutical, manufacturing and laboratory system.
Opportunity is Calling, APPLY NOW!
WHAT'S IN IT FOR YOU*
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
* Medical, Dental & Vision Benefits
* 401K Retirement Saving Plan
* Life & Disability Insurance
* Direct Deposit & weekly ePayroll
* Employee Discount Programs
* Referral Bonus Programs
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Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here:
to contact us if you are an individual with a disability and require accommodation in the application process.