Manufacturing Validation Engineer - Tipperary.
Job Title: Manufacturing Engineer Location: Clonmel, Tipperary Industry:Medical Devices Company information: A large Multi-National Medical device company, leading for over 40 years Role Profile Responsible for the introduction, qualification / validation of new equipment.
Executing Protocols - IQ/OQ/PQ 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.
Understandsand complywith all the regulations governing the quality systems.
Ensures alldirect 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 / Professional Skills / Knowledge Degree required:Level 8 bachelors related engineering degree: mechanical, manufacturing etc Proven experience:2-5years minimum experience, automated manufacturing experience an advantage Equipment qualification / installation / validation desired Contact Information For a confidential discussion or to find out more, please contact: Gary Keane Email: Phone: INDCRG Skills: Manufacturing Engineer Production Engineer Process Engineer Validation qualification equipment.
IQ OQ PQ protocols installation