Process Validation Engineer

Job#: 2014429

Job Description:

The Robotic And Digital solutions group, part of the Ethicon Medical Devices sector within Johnson & Johnson, is recruiting for a Process Validation Engineer NPI, located in Santa Clara, CA.
Pay: $70-90/hour on W2
1 Year Minimum Contract
 
Summary
The Process Validation Engineer NPI is responsible for acting as a team member on process and product development projects conducting various assignments in cooperation with direction of team & team leader.
Scope of responsibility included characterizing, qualifying and validating equipment and process needed for robotic assembly, dispensing, and/or packaging components and/or products. Conducts and drives Process Characterization, TMV (Test Method Validation) and Risk assessment activities.

  • Supports investigations to determine root cause of failures, presents results, and proposes corrective and preventative actions as required to support CAPA.
  • Collaborates and interacts with other company teams, including NPI Engineering, Development/Operation Quality, Regulatory, and Program Management.
  • Provide engineering, risk assessment, and statistics support in the development and maintenance of the company’s quality systems.
  • Follows domestic and international regulatory standards (e.g., GxP and ISO 13485).

 
Responsibilities:

  • Works under general supervision.
  • Perform process validations as required, IQ/OQ/PQ; generate protocols and test reports.
  • Act as technical liaison between Quality Engineering and Manufacturing.
  • Complete validation assignments involving TMV, Process Characterization, DOE.  
  • Understands and applies test methods to locate, reproduce, identify, and analyze complex failures.  Develop Process Failure Mode and Effects Analyses. 
  • Apply comprehensive & diverse knowledge of engineering principles to assignments.
  • Co-ordinate activities with internal & external customers and suppliers.
  • Authors and reviews technical protocols, reports, standards and change orders.
  • Participates in presentation of progress and results to all levels of organization.
  • Generates monthly status reports on individual activity.

 
Qualifications:

  • A minimum of a Bachelor of Science Degree in a technical field (for example, Electrical Engineering, Mathematics, Statistics, Mechanical Engineering, Industrial Engineering, Chemical Engineering, etc.) is required.
  • A minimum of 3 years of experience in a technical field is preferred.
  • Experience with GR&R, FMEA (Failure Modes Effects Analysis), DOE and process characterization is preferred.
  • Experience with Process Validation (IQ/OQ/PQ), able to generate protocols and test reports.
  • Experience with statistical analysis software tool such as MiniTab is preferred.
  • Knowledge of LEAN/ Six Sigma and Process Six Sigma is preferred.
  • Understanding of Statistical Analysis used to identify issues in post-market surveillance, complaints, and servicing is preferred.
  • Understanding of Risk Management (Medical Device) is preferred.
  • Strong integration skills to identify Manufacturing and Supplier related issues of Medical Device Capital Equipment is preferred.
  • Demonstrated ability to work effectively with cross-functional teams for qualifications, verifications, validations, complaint investigation, root cause analysis, identification and implementation of CAPAs is preferred.
  • Ability to multi-task with an established track record of meeting milestone schedules is preferred.
  • Prior experience or training in Validation Engineering is preferred.
  • Experience working in an ISO13485, GMP, or FDA regulated environment is desirable.
  • Excellent communication skills, both verbal and written, and the ability to effectively interface within a cross-functional teams.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Employee Type:
Contract

Location:
Santa Clara, CA, US

Job Type:
Engineering and Technicians

Date Posted:
February 5, 2024

Pay Range:
$75 - $85 per hour