Senior Project Lead

Senior Project Leader

Location: Cork Ringaskiddy

Duration: 6 Months

Hours: 39

Imagine your next project utilising project management best practices for the effective and efficient development of savings type projects on the Value Capture Program for an iconic global healthcare company.

Senior Project Leader in the Engineering Department. The role involves utilizing project management best practices for the effective and efficient development of savings type projects on the Value Capture Program. The incumbent will also utilise Engineering principles and Lean problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision of site’s goals. They will be tasked at the identify, scope, design and lead several projects.

roles and responsibilities.

• Team member representing the End 2 Engineering function supporting projects with a focus on Quality, Savings, Capacity, Validation type projects used in the manufacturing processes across the entire Orthopaedic Range of Products

• Prepare several documents on the projects – scoping, designing, implementation & execution

• Support colleagues to complete several project related tasks

• Responsible for ensuring design of new manufacturing process improvements are aligned with operation's needs, quality, EHS, validation, finance, automation, maintenance requirements.

• Determine operations & process inputs and outputs ranges of machine prior to commencing validation

• Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ, OQ, PQ) 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.

how to succeed.

• MSc to BSc in Engineering or Science with 7 years’ experience in a medium to high volume manufacturing environment

• 2 year in a similar capacity in a regulated industry (i.e. FDA/ISO)

• 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

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months

you are welcome here.

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process.

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

We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert.

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”.