I am delighted to be assisting this well-known highly respected manufacturing company in Shannon find a Validation Engineer to join their team. It is a fabulous place to work. They really know how to look after their staff and have all of the state-of-the-art equipment and technologies. They work with leading medical device multinationals in Ireland. This is an excellent opportunity for someone who wants to get great exposure working on innovative projects. They have over 150 staff with very low turnover and when you meet them you can see why! Every Engineer who has gone there through me I have assisted them through the process. After they have met this company at interview stage, they always want the job and no Engineer has turned down their offer. They have a highly attractive package including pension and health insurance. The Validation Engineer will implement and manage the creation, revision and delivery of GAMP documentation to FDA regulated companies in accordance with approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements. Responsibilities: Generate validation documentation including risk assessments, traceability matrix and validation plan/reports. Develop and review software validation test protocols including FAT & SAT protocols. Participate in FAT and SAT protocol execution, as necessary. Collate and organise all qualification files for the projects (including Test protocols, Reports etc. Document, Investigate and report all deviations/exceptions during the qualification activities. Co-ordinate qualification activities with contractors and vendors as required. Requirements: Level 8 Degree - BSc / BEng. 3-5 years experience in a validation role in either Medical Device or Pharmaceutical Industry. Knowledge of Computer System Validation including GAMP 5, 21 CFR Part 11 and cGMP requirements. Proven track record in developing validation document for the pharmaceutical and medical device industry. Ability to multitask and manage multiple projects simultaneously. Excellent technical skills including proficiency in Word, Excel, PowerPoint & MS Project. For a confidential discussion please call Emer on 0860437889. This job originally appeared on RecruitIreland.com.
66 days ago