Re-Validation
Life Science Consultants Ltd
Limerick
Re-Validation Engineer is required for an innovative and rapidly growing Biopharmaceutical company in Limerick . The new facility is close to completion and is responsible for the production, packaging, labelling and delivery of biopharmaceutical medicines for global markets. The company currently markets medicines for various diseases and has a rich pipeline of products. The team on site strive to create a culture of trust, teamwork, transparency, respect and a drive to continuously improve. This organization has an exceptional reputation based on commitment to their employees, culture and patients and have won several #1 employer awards. If you want to succeed on a new and growing site, with innovative medicines and in an atmosphere which is intense, face paced and exciting then this is the opportunity for you. The Re-Validation Enigneer will : Completes Document Preparation and Field Execution activities for the initial Qualification and Validation of the facility. 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. The Re-Validation Engineer requires: A BSc in eningeering or a related field with a min of 4 years Validation experience. Experience in Validation specifically continuing (other companies may call it re-validation or maintaining a qualified state in relation to equipment. Experience in gap analysis assessments and technical writing. Experience in Deviation/Change control writing, Experience in continuing assessments of equipment, An excellent understanding of how manufacturing/Cleaning Validation/HVAC equipment works. Call Ruth at LSC on 021 4777329 for more information on this new Re-Validation role, or apply directly via this advert. This job originally appeared on RecruitIreland.com.
2768 days ago