An Automation Project Engineer is required by CareerWise Recruitment for our Galway based client. The Automation Project Engineer will support automation projects end-to-end, including concept, design, implementation, and validation. Working with various cross-functional teams, you will be responsible for designing, implementing, maintaining, and optimizing automation systems and equipment. This role ensures compliance with regulatory standards and supports continuous improvement initiatives to enhance production efficiency, product quality, and data integrity. This is a 5-day On-site role THE ROLE: Develop, configure, and deploy PLC, SCADA, DCS, MES, and HMI automation systems. Implement process control strategies to optimize manufacturing and laboratory operations. Collaborate with cross-functional teams (Engineering, IT, Quality, Production) to integrate automation solutions. Provide technical support for automation-related issues, minimizing downtime. Conduct root cause analysis (RCA) and implement corrective actions for system failures. Ensure systems are validated, calibrated, and maintained according to regulatory requirements. Ensure adherence to cGMP, FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and other regulatory standards. Develop and maintain technical documentation, including URS, FDS, HDS, SDS, IQ/OQ/PQ protocols. Participate in regulatory audits and inspections, providing automation-related compliance support. Drive process automation enhancements to improve manufacturing efficiency and reduce operational costs. Stay updated on emerging technologies in Industry 4.0, IoT, data analytics, AI-driven automation. Support digital transformation initiatives such as cloud-based automation and electronic batch records (EBR). REQUIREMENTS: Bachelors or Masters degree in Automation, Mechanical, Electrical, or Industrial Engineering (or related field). 35 years of experience in automation within the pharmaceutical, biotech, or life sciences industry. GAMP 5 Practitioner Certification Certified Automation Professional (CAP) Six Sigma / Lean Manufacturing Certification PMP (Project Management Professional) Expertise in PLC programming (Siemens, Allen-Bradley, Schneider, etc.). Experience with SCADA/DCS systems (Wonderware, DeltaV, Rockwell, Siemens PCS7, etc.). Knowledge of MES (Manufacturing Execution Systems) such as Werum PAS-X, Rockwell PharmaSuite. Proficiency in industrial communication protocols (OPC, Modbus, Profibus, Ethernet/IP). Familiarity with robotic automation, vision systems, and data analytics tools. Basic scripting/programming (Python, SQL, VBA, C#) for data handling and automation tasks. Strong problem-solving and troubleshooting skills. Excellent communication and collaboration with cross-functional teams. Ability to work in a regulated environment and handle documentation. Please call Tom Devaney today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices inCork,Shannon,Galway,Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: Automation Automation Engineer Automation Project Engineer