Validation Engineer – Princeton, NJ


Validation Engineer

Intellilink Technologies

Princeton, NJ

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Job Descriptionn

· Develop and execute validationnand equipment qualification protocols to meet regulatory requirements.

· Assess and develop any amendmentsnto the qualifications to deliver fully validated equipment into productionnwithin agreed timelines.

· Provide guidance to sites withnrespect to validation/process deviations and change control as it pertains tonsystems and test equipment in production.

· Support the validation program and proceduralnchanges that enhance safety, compliance, and overall operational efficiency.

· Support the site’s adherence to the ValidationnMaster Plan.

· Continuously evaluate and identify opportunitiesnfor improvement in existing validation programs and procedures.

· Participate in device risk management activitiesnincluding DFMEA and PFMEA.

· Provide direct technical support on productionnissues (e.g. part & assembled product quality dispositions, interimncontainment actions, root cause analysis, resolution planning, validation,n& implementation) under NCMR or CAPA.

· Able to develop all documentation required for a 21nCFR Part 11 validated project, including Validation Plans and Summaries.

· Approve validated computer system related changenrequests.

· Assist in planning, implementing, and documentingnuser acceptance testing.

 

Qualification:

This position requires a minimum of Bachelor’sndegree in Mechanical Engineering, or closely related field. 

Job Tagsn

Validation Engineer

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