Ireland Biomedical jobs

Manufacturing Engineer – Clonmel (Hybrid)

About the role:
Our Cork based client are now recruiting for a Manufacturing Engineer to join their team. An excellent Hybrid working opportunity to work with a thriving medical devices company. The role would involve working in our pharmaceutical quality system supporting commercial production of our pharma product.
The successful candidate will be responsible for providing daily support of and equipment, processes, materials, in order to achieve production goals along with develop and implement manufacturing business improvement process improvement projects and processes working with Automated Equipment. The role is heavily involved with equipment line moves, equipment validation, equipment qualification, process improvements, line upgrades.
Responsibilities:

• Responsible for the introduction and validation of new equipment.

• Analyses process, product, material or equipment specifications and performance requirements.
• Work with cross-functional teams to identify and resolve production/engineering issues.
• Summarises, analyses, and draws conclusions from test results leading to effective technical resolution.
• Transfer and validation of equipment from one clean room to another.
• Continuous Improvement & Yield Analysis.
• Continually seeks to drive / improvements in process equipment design, layout and operational performance.
• Engaging with technicians, operators, and other cross-functional teams to ensure business process success.
• Contribution in NPI (New Product Introduction) development
• Root cause analysis using Lean tools and techniques.
• Writing and improving process procedures.
• PCA (Process Change Analysis) From Documentation to Implementation
• Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
• Actively promotes and participates in a cross -functional teamwork environment.
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Gives technical guidance to Associate Engineers and technicians.
• Understands and comply with all the regulations governing the quality systems.
• Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

Qualifications and Experience:

• NFQ Level 8 in a Technical Discipline (Science, Biomedical, Mechanical, Manufacturing, etc.)
• Minimum 2-5 years’ experience working at an Engineering level, ideally in Medical Device industry or other highly regulated environment.
• Project Management experience advantageous.
• Automated Manufacturing equipment experience advantageous

INDTRAC