To ensure the successful delivery of investment at our Dublin site, by leading automation projects and workstreams. To secure the supply of product to our patients by supporting manufacturing activities, our client is looking for a freelance Automation Engineer M/W in Dublin

Your missions will be: Project management: Manage specialist automation and digital projects, including: * Project definition and URS creation with end users * Management & co-ordination of project governance (schedule, costs, stakeholder management, procurement) * Creation and/or coordination of design activities * Review of vendor designs and documents * Coordination of testing, installation, commissioning, and qualification Creation and/or coordination of handover pack, including manuals, training, standard operating procedures (SOPs), automation PPMs Project support: Support capital projects by providing automation and digital knowledge to the Project Manager throughout the project, including: * Project definition and URS creation with end users * Leading automation and digital workstreams * Creation and/or coordination of design activities * Review of vendor designs and documents * Coordination of testing, installation, commissioning, and qualification * Creation and/or coordination of handover pack, including manuals, training, standard operating procedures (SOPs), automation PPMs Manufacturing support: Provide automation and digital expertise to internal customers (Maintenance, Production, Quality) to ensure the availability, performance and compliance requirements of manufacturing equipment are met * Investigate and implement improvements to manufacturing equipment * Provide automation and digital expertise when required in regulatory audits Computerised System Lifecycle: * Generate disaster recovery plans and procedures for new computerised systems * Support validation activities for new computerised systems (commissioning, qualification, startup) * Create maintenance procedures for new computerised systems * Develop SOPs for new computerised systems * Support maintenance and requalification activities on computerised systems throughout their life * Develop and maintain a robust obsolescence strategy for computerised systems * Decommission end of life computerised systems Quality System: * Complete quality-related activities (changes, unplanned events, CAPA) in accordance with quality-management systems * Complete documentation to Good Documentation Practices * Undertake training as required to maintain compliance

Education / Certifications: * Bachelor’s Degree in electrical, automation and/or instrumentation, or related engineering field Experience: * Diagnostics and maintenance of PLC, HMI, and SCADA systems, preferably within a cGMP regulated environment * Experience with Siemens PLC/HMI/SCADA (Step 7, WinCC Flex 20008, TIA Portal, WinCC/PCS7) * Writing and reviewing technical documents (specifications, technical reports, risk assessments) * Project management experience (e.g., scheduling, budget control, stakeholder management, vendor liaison) * Experience with additional PLC/HMI/SCADA manufacturers preferable * Awareness of regulatory expectations around computerised systems (GAMP5, FDA 21 CFR11, EU ANNEX 11) preferable * Experience working with regulated electronic document and quality systems preferable

Start date: ASAP Location: Dublin Duration: 1 year minimum

Rodolphe Szymczak Talent Community Specialist Infrastructure & Cloud +33 7 57 91 43 37 [email protected]