Junior Project Engineer - CORK

Job Title:    Project Engineer   
Department:    Engineering Projects   
Reports To:    Sn Engineer or Team Leader    
Location:    Cork Ringaskiddy


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.

The Project:

Project Engineer in the Engineering Department. The role involves utilising project management best practices for the effective and efficient development and/or transfer of products/processes into commercial operations. The incumbent will also utilise 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 be tasked at the design, procurement, installation, validation of assets that will be involved in the manufacturing of Knee/hip construct.
 

The Role:

• 12 Month Contract, High Likelihood of extension
• Onsite in Depuy, Ringaskiddy, Cork
• €23-27 p/h PAYE (Higher Umbrella Options Available)
   

Duties and Responsibilities:

• Team member representing the Engineering function supporting projects with a focus on capacity expansion, install, validation, of assets used in the manufacturing processes.
• Prepare several documents as part of the IQ, OQ, PQ processes. 
• Support colleagues to complete several tasks
• Responsible for ensuring design of machine is aligned with operations needs, quality, EHS, validation, quality automation, maintenance requirements. 
• Validate the machine as per the specifications, procedures, regulations  
• Determine operational & process inputs and outputs ranges of machine prior to commencing validation 
• Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s of assets and associated machines. 
• Develop pFMEA documentation to support processes as part of Validation process
• Partner with Quality, Operations, CSV and other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.  
• Communicate effectively with project manager and other managers, global functions and internal team on status of project(s) tasks, issues and requirements.
• 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.
• Work with vendor to ensure design specification documents meet site requirements
• Ensure asset meets requirement specifactions as per agreed User Requirement Specifiaction (URS)
• Complete testing with vendor to ensure parts are processed correctly, effiently and meet quality requirements
• Develop training documentation and supply training to appropriate function for general asset operation, recovery methods and preventative maintenance

Professional Experience Required:

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)
• Understanding of the Mechanical Engineering process and Process Validation expertise is preferred
• Strong verbal and written communication skills 
• Knowledge of Cognex vision system for support of vision job files using insight explorer
• Knowledge of dataman scanners
• Training in robotic loading systems, preferably Fanuc and ABB

In Return:

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

Things to remember before applying for this role:

• The pay rate for this role will depend on how you are paid (PAYE or Umbrella options).
• We are looking to process the first round of applications within the next 2 working days.
• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

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

If you would like some additional information about the role please contact: Courtney.wells@randstadsourceright.co.uk 

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 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”.