Senior Manufacturing Engineer
RK5844
Contract 12 months
Cork



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



The role involves utilizing project management best practices for the effective and efficient development of savings type projects. They will also utilize 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 on reducing Scrap, Consumables usage, Direct Labour wastage.



Duties:

• Team member representing the End 2 End 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 identifying savings on site linked to Direct Labour inefficiencies, Scrap, Consumables spend.
• Ensuring new or amended manufacturing process improvements are aligned with operation's needs, quality, EHS, validation, finance, automation, maintenance requirements, seeking collaboration and funding for the project with Senior Leaders.
• Presentation to Senior Management Weekly on Status or need for funding
• 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.
• 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.

• MSc in Engineering or Science with 7+ years’ experience in a medium to high volume manufacturing environment - Food Processing, Paint Industry, Oil & Gas, Orthopedics
• 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/Lean Manufacturing experience projects using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.