QA Validation

Independent Solutions

Limerick

Our client in Limerick is seeking a Contract QA Validation Engineer. SUMMARY/POSITION OBJECTIVE: Completes Document Preparation and Field Execution activities for the initial Qualification and Validation for the facility. Team Lead and Team Member positions to be filled in the following areas: Clean Utilities. HVAC. Upstream. Downstream. CIP (may include Cleaning Validation. SIP (including Thermal/Temperature Mapping. QC Labs. JOB DUTIES: Essential Duties and Responsibilities include, but are not limited to, the following: Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval. Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ, Cleaning Validation protocols; drive approval of same. Execute IQ, OQ and where necessary PQ protocols and drive post-approval of same. Interface with Regeneron Commissioning and Process Sciences teams. Support CIP and SIP validation programs as necessary. Support Regeneron Management in Project delivery. JOB REQUIREMENTS: Skills, and abilities required to perform the job. 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 : 5 years 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.

2132 days ago