Summary: Our client, a biopharmaceutical located in South Dublin, is seeking an Automation Engineer.
The ideal candidate will be a Subject Matter Expert (SME) in Manufacturing Control Systems, Operational Technology, Machine Automation, and Digitalization.
The incumbent will play a crucial role in ensuring the optimal performance of our automation systems and driving digital transformation projects.
Responsibilities: Oversee automation systems to ensure maximum uptime and performance.
Manage system user access, backups, and restores.
Implement corrective actions and collaborate with vendor technical support.
Identify and execute small projects to enhance system performance.
Contribute to capital planning, project execution, and documentation.
Ensure all activities comply with site and corporate Quality Systems.
Create and maintain engineering deliverables and test scripts.
Develop and implement global automation strategies to standardize processes.
Maintain and optimize automation systems and infrastructure.
Develop solutions tailored to the manufacturing environment.
Drive automation projects, ensuring cost, schedule, and technical goals are met.
Stay updated with technology trends and benchmarks to keep our client at the forefront.
Qualifications & Experience: Degree in Engineering (Automation, Robotics, Computer Science, or a related field) or equivalent.
Minimum of 5 years' experience in GMP manufacturing, with a focus on automation.
Strong understanding of pharmaceutical manufacturing processes and regulatory environments.
Experience in the pharmaceutical industry is an advantage.
Proficiency in automation solutions, including Siemens, Omron, and Mitsubishi.
Knowledge of industry standards such as GAMP, ANSI/ISA, 21 CFR Part 11, Annex 11, and GxP/QA.
Familiarity with ANSI/ISA-99 and ANSI/ISA-100 standards is a plus.
Fluent in written and spoken English.
Skills: GAMP ISA Annex 11 QA English GMP