Cleaning Validation

Independent Solutions

Limerick

Essential Duties and Responsibilities include, but are not limited to, the following: Experience in Continuing Validation (re-validation or maintain a qualified state in relation to equipment/Utilities. Experience in gap analysis assessments. Experienced technical writer. Experience in Deviations/Change control writing. Experience in continuing assessments of equipment. Capable of managing a large program, so project management skills would be necessary. An excellent understanding of how manufacturing/Cleaning Validation/HVAC equipment works. Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ protocalls, Tracematrix, Summary Report and drive post-approval of same. Interface with Commissioning, Process Sciences and Manufacturing teams. Proven BioTech experience in the given area, as follows: Lead position : 5 years BioTech C&Q experience, of which 2 years as a working Lead. Team Member position : 5years BioTech experience C&Q. Experience in Document Preparation and Execution. Experience in major start-ups where construction, C&Q, PQ may be concurrent activities. Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing. Have Troubleshooting and analytical mindset. Minimum Years of Experience: 5 years. Minimal educational requirements: B.Sc, B.Eng. This job originally appeared on RecruitIreland.com.

2233 days ago