Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

Johnson & Johnson

Quality Engineer (Validation)

Posted Jul 1, 2022
Job ID: JJJP00011570
Location
Cork
Hours/week
39 hrs/week
Timeline
1 year
Payrate range
Unknown
Application Deadline: Jul 5, 2022 12:00 PM

Position: Quality Engineer - Validation


 

Location: Ringaskiddy, Cork 


 

Work type: Hybrid ((Most of the work will be done remotely and you will only asked to work on site, when needed). 


 

Start date: As soon as possible


 

Contract duration: 12 month 


 

Hours: 39 hours a week


 

Hourly pay rate:  €27 - €30

 

Please note, The rates advertised relate to PAYE contractors, higher rates available for those that work via an Umbrella or Limited company 




 

The Company:


 

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.



 

Overall responsibilities:


 

The role involves utilising Quality Engineering tools and practices for the effective and efficient development and/or transfer of products/processes into commercial operations. The incumbent will also utilise Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilise appropriate risk management to prevent unanticipated failure modes and improve the capability of processes.






 

Position, duties and responsibilities:


 

  • Team member representing the Quality function supporting projects with a focus on metals forming processes.
  • Support Quality and Validation activities for product transfers and new product introductions.
  • Responsible for ensuring conformance with current equipment, process, and systems validation regulations.
  • Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.
  • Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis).
  • Determine process inputs and factors for variation where process capability is required.
  • Responsible for reviewing Installation, Operating and Performance Qualification (IQ,OQ, PQ)s.
  • Responsible for conducting Test Method Validations as required
  • Develop/Review pFMEA documentation to support processes as part of Validation process
  • Partner with other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.  
  • Conduct investigation, bounding, documentation, review and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate.
  • Support root cause analysis activities related to material processes.
  • Communicate effectively with the internal team on actions and deliverables.
  • Provide timely and accurate reporting and management of escalations as appropriate on project activities.
  • Ensure all activities comply with GMP, ISO and quality system requirements.
  • Ensure that all health, safety and environmental requirements are fulfilled.




 

Education & Experience Requirements:



 

Essential:


 

  • BSc in Engineering or Science with >2 years’ experience in a medium to high volume manufacturing environment 
  • 1 year in a similar capacity in a regulated industry (i.e. FDA/ISO)




 

Desirable: 

 

  • Experience working in both an FDA and European regulatory environment is preferred with an in-depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
  • A thorough understanding of GMP/ISO and validation regulations. 
  • Technical training (Six Sigma Black Belt / Statistical Engineering) and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
  • Problem solving engineering expertise (Six Sigma, SE or A3)
  • Strong verbal and written communication skills 




 

In return for this role, you will receive a competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader with Johnson & Johnson.


 

Things to remember before applying for this role:


 

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email.

 



 

Diversity, Equity & Inclusion:

 

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.


 

Thank you very much and we look forward to receiving your application.


 

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