Senior Manufacturing Engineer

• Industry Pharma/Biotech/Clinical Research
• Work Experience 5+ years
• City Cork
• State/Province Cork
• Country Ireland

Job Description

Summary:

• 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 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 goals on reducing Scrap, Consumables usage, Direct Labour wastage. He/she will be tasked at the identify, scope, design and lead several projects.
• 12 Month of contract role

Requirements

Responsibilities:

• Team member representing the End 2 End Engineeringfunction 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 & dash;scoping, designing, implementation & execution
• Support colleagues to complete several project relatedtasks
• Responsible for identifying savings on site linked to Direct Labour inefficiencies, Scrap, Consumables spend.
• Ensuring new or amended manufacturing processimprovements 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 crossfunctional partners to ensure the correct application of design controls, riskmanagement and the investigation/correction of design 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 qualitysystem requirements.
• Ensure that all health, safety and environmentalrequirements are fulfilled.

Education & Experience Required:

• MSc in Engineering or Science with > 7years' experience in a medium to high volume manufacturingenvironment - Food Processing, Paint Industry, Oil & Gas, Orthopedics 2 year in a similar capacity in a regulated industry(i.e. FDA/ISO) Work from the office to hands on with fellow Engineer's development of trials, experiments, development ofprojects.
• Experience working in both an FDA and European regulatoryenvironment 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 validationregulations.
• Technical training Six Sigma/Black Belt/LeanManufacturing experience projects using Statistics, Lean and Six SigmaMethodologies 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