Validation Engineer

Quanta Consultancy Services Ltd
40 - 50 per hour
04 Nov 2017
16 Nov 2017
Contract Type
Full Time
Position: SIP Team Executor Rate dependant on experience and abilities. Opportunity to work for a global biotechbology organisation in Ireland. SUMMARY/POSITION OBJECTIVE: Completes Document Preparation and Field Execution activities for the Cleaning Validation Program. Team Member positions to be filled in the following areas: - Cleaning/ SIP Validation JOB DUTIES: - Experience in Validation specifically cleaning validation and thermal mapping - Experience in assessment of cleaning issues during study runs, - Placement of thermocouple probes in vessel and transfer lines - Experienced Technical writer, - Experience in Deviation/Change control writing, - Capable of managing a large program, so project management skills would be necessary, - An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment/ Theemal maapping works - Troubleshooting of thermal mapping studies for investigation and Engineering studies - Understanding of baseline studies for new equipment - Experienced in coverage testing and clean-into-service - Generate/review/Approval of CV/ SIP protocols, - Generate Reports - Maintain and update Cleaning/ Steam in place Validation Plan - Schedule of cleaning/SIP activities with Manufacturing - Liaise with numerous departments JOB REQUIREMENTS: Skills and abilities required to perform the job. - Proven Biotech experience in the given area, as follows: - Validation engineer position: 3-5 years Biotech cleaning/SIP validation experience - Experience in Document Preparation and Execution - Experience in major start-ups where clean-into-service, coverage testing, baseline studies in commissioning area, and cleaning and SIP validation studies may be concurrent activities in different trains. - Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing. - Have Troubleshooting and analytical mindset. Minimum Years of Experience: 3-5 years Minimal educational requirements:B.Sc, B.Eng.
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