Ref No: AM17961
County Wicklow, Republic of Ireland
Instrumentation Engineering Technician - North Wicklow.
Purpose of job:
The primary responsibility will be the maintenance of the instrument analyser equipment. This will include the planning and performing of the maintenance of all the analyser equipment and ensuring that instrument downtime is minimal, while ensuring analyser performance is to the highest required standards.
The Instrumentation Engineer Technician will work with R&D, Manufacturing and QC departments and also in close association with Technical Customer Support. Responsibilities will include the technical life cycle management of the company's and 3rd Parties’ instrumentation ranges, integration of next generation instruments, and global instrument standardisation throughout the installed customer base.
Additional responsibilities will include the planning and co-ordination of all engineering change activity (e.g. Technical bulletins) associated with the development and upgrade of the instrumentation range, including updating Operator and Service Manuals (in close association with Marketing and ASA). Complaint Management for instrument related CAPAs incorporating, design change, SOP, support Literature, field technical bulletins.
All duties performed in an FDA regulated environment where knowledge and adherence to Standard Operating Procedures within the Quality System is required.
• Perform planned/unplanned maintenance of the instruments at the plant.
• Life cycle management of all analyser equipment.
• Assist in design, development and implementation of a global instrument standardisation system for the company's installed instrument base.
• Co-ordinate root cause investigations and reporting on instrumentation related failures as identified through such channels as validation, customer complaints, event and audit findings, and service histories.
Qualifications and Experience requirements:
• Third level Mechanical, Electronic or Software Certificate, Diploma or Engineering degree with at least 3 years’ experience in an FDA regulated environment (Instrumentation, Maintenance, Manufacture, Design or Validation).
• Working knowledge of FDA and ISO Quality System Requirements as they relate to diagnostics instrumentation.
• Excellent written and verbal communication skills with specific emphasis on technical report writing.
• Ability to work on own initiative as an individual or as a team member.
• Attention to detail/quality orientation with a strong customer focus.
• Problem Solving / Root Cause investigation.