Technical Writer required for a leading medical device company based in Limerick. The companies FDA regulated Limerick facility has grown consistently over the last 20 years to become one of the most important sites in its global operations. This facility specialises in the production of disposable contact lenses in a state of the art operation which includes injection moulding, robotics, vision systems and sterilisation systems in a Class 100,000 cleanroom environment. The facility has over 50 fully automated manufacturing lines and the product is untouched by a human hand from start to finish of the process.
If you are looking for an opportunity to work in a leading edge medical device facility with a focus on process innovation, automation and continuous improvement with steady personal growth and development opportunities then call us to find out more.
In this role theTechnical Writer will:
o Perform technical writing activities and assist the project engineers in the generation of all validation documentations including URS’s, FAT’s, SAT’s, test plans, deviations and discrepancies.
o Update and edit Operations Procedures and Work Instructions, project manuals, project presentations and reports.
o To provide assistance with Change Control process to ensure that change implementation activities and deliverables are coordinated effectively in order to meet both the TRB and CCB requirements and timelines.
o Help coordinate FMEA sessions with Engineering as needed.
o Assist with attachment and upload of deliverables associated with change control.
o Help with non-critical Validation execution under direction of Engineering.
o Assist with purchasing and spare parts ordering Support Engineering with planning and department development.
The Technical Writer requires:
o Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base
o Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
o Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
o Desirable: Experience working in a regulated environment would be an advantage
If this role is of interest, please call Mairead at LSC on 021 4777 329 or apply directly through this advert