Performance Evaluation Compliance Engineer

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
R&D Operations

Job Sub Function:
Laboratory Operations

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

We are searching for the best talent for a Performance Evaluation Compliance Engineer located in Raritan, NJ.

Purpose: Our Performance Evaluation Engineer will make vital contributions to the New Product Development and Lifecycle Management pipeline and transform patient care through innovation.

They are responsible for working with our project teams to develop and execute clinically relevant predictive bench-top models to advance the standard of care in medical devices.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:


* Overall main point of contact for any GxP related laboratory issue


* Provide laboratory support during internal and external audits.


* Maintain laboratory compliance to GxP procedures, including maintenance of laboratory logbooks, issuing and approving data sheets and logbooks, and sample storage room administrator.


* Conduct laboratory and audit failure investigations and initiate and own any subsequent non-conformances.


* Support compliance of laboratory software systems (for example, Bluehill for Instrons or other Part 11 Compliance software).


* Training and records coordinator.


* Identify and conduct test method validation remediation for legacy physical test methods and updates to documents in applicable document management system.


* Identify and procure new test equipment and perform validation activities such as installation qualification, performance qualification and computer software validation.


* Assist with implementation of electronic laboratory notebook system to enable paperless system


* Maintain equipment including performing equipment/software validations, arranging for calibration and preventative maintenance and write/maintain equipment standard operating procedures

Education:


* Bachelor's degree in Materials Science & Engineering, Biomedical Engineering, Mechanical Engineering, or Chemical Engineering or other related field

Required Skills & Experience:


* A minimum of 2 years of relevant experience is required with a Bachelor’s or an Advanced Degree with a minimum of 1 year of relevant experience...