QA Validation (Contract)

Independent Solutions

Limerick

SUMMARY/POSITION OBJECTIVE: Completes Document Preparation and Field Execution activities for the Continuing Qualification and Validation of the Regeneron Limerick BioTech facility. Team Lead and Team Member positions to be filled in the following areas: Clean Utilities. HVAC. CTU/Warehouse. Upstream. Downstream. CIP (may include Cleaning Validation. SIP (including Thermal/Temperature Mapping. CSV. QC Labs. JOB DUTIES: 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 Regeneron Commissioning, Process Sciences and Manufacturing teams. 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 : 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.

2267 days ago