Compliance Automation Engineer required for a leading Biotech facility in Co. Meath, responsible for supporting DMO Compliance activities at the single use multi-product biotech facility. Initially an 11 month contract. Role: Ensure permanent inspection readiness within the DMO team. Support generation/review/approval of CSA deliverables. Providing ongoing compliance (GxP, Financial, Data Privacy) coaching and support to all team members. Manage deployment of Global SDLC/CSA and IT Security policies and procedures. Ensure supply of all compliance components required to deliver high quality product through tactical planning and execution of project and compliance deliverables, including change-control, periodic reviews, performance monitoring, system administration, access administration, disaster recovery, deviations, incident problem management/investigations, CAPAs, audits, policy deployment, cyber security, data integrity, EHS, training etc. Ensure highest Quality, EHS & Compliance standards. Active participation in the Tier process and proactively resolving issues. Liaise with Compliance Engineers from other areas and support Site Quality Council and other site quality initiatives. Coordinate AIT Change-controls, EHS activities and EHS/Quality metrics Completion of AIT Investigations, root-cause analysis and CAPA's Strong project management skills to support project delivery and operational readiness. Requirements: At least 4 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant. Degree qualification (Science, Engineering, Technical). Preference for Lean Six Sigma Green Belt. Desirable to have qualification in Project Management and Computer Validation. Very Strong Collaboration, Compliance and Communication Skills A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required. Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments). Experience in PLC/SCADA/DCS systems Skills: Compliance Automation CSV Engineering