Project Engineer in the Engineering Department. The role involves utilizing project management best practices for the effective and efficient development and/or transfer of products/processes into commercial operations. The incumbent will also utilize 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
Roles 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
How to Succeed
Technical degree in related discipline (Engineering/Science/Chemical) preferred.
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)
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
This role offers a very competitive hourly rate. This contract will run for 12 months
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”.
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