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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
• Experience working in a highly regulated environment,
• Demonstrated collaboration, teamwork, and influencing skills, with the ability to interact with group members and internal/external auditors
• Knowledge of failure and laboratory investigation techniques
• Knowledge of general laboratory testing techniques

Preferred Skills & Experience:

• Experience with equipment and test method validation
• Experience with physical and mechanical testing of polymer materials using a computer-controlled testing equipment, such as Instron or equivalent equipment

• Knowledge or experience with quality system regulations (21CFR) and Good Manufacturing and Documentation Practices
• Medical device environment (cGMP)

Other:

• This position is based in Raritan, NJ, and requires up to 10% travel

The anticipated base pay range for this position is [$85, 500] to [$110, 000]

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.

For additional general information on company benefits, please go to: - https: //www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.