Senior Automation/Controls Engineer II
hace 5 días
Lexington
Our pharmaceutical client is seeking a hands on Senior automation engineer II that has experience with GAMP5 along with designing, programming, monitoring and maintenance of production and facilities process automation systems. If you want to be a part of a fast, stable and growing organization, this role might be the one for you! Responsibilities: • Design, develop, and implement automated systems, including software, hardware, and processes., • Analyze existing systems, identify areas for automation, and create solutions that meet specific needs., • Configure and/or manage site-level automation systems (e.g., serialization, data historian, reporting, industrial networking)., • Lead the design and procurement of new process and utility equipment and lead installation, start-up, commissioning or qualification activities, including authoring and/or reviewing IQ/OQ/PQ protocols, test execution, and authoring summary reports., • Support the development of site automation standardization and/or technology master plans., • Write scripts and code to automate tasks, processes, and workflows using various programming languages., • Test and optimize automated systems to ensure they function correctly and efficiently., • Identify and resolve issues and continuously improve system performance., • Implement improvements to existing equipment used to manufacture and package multiple types of nasal spray drug products., • Troubleshoot and resolve issues with automated systems, ensuring they operate smoothly., • Diagnose problems, implement fixes, and perform maintenance tasks., • Support maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances and intervals, drawing updates, execution of automation-related PMs (e.g., backup/restore), and support of out-of-tolerance investigations related to instrument calibrations., • Collaborate with other engineers, technicians, and stakeholders to develop and implement automation solutions. Basic Qualifications: • BS in engineering/related degree or equivalent experience., • 8+ years of related experience; or 6 years with a master’s degree, or 3 years with a PhD., • Experience with a variety of PLCs, HMI hardware, and industrial sensors and applications., • Controls design experience., • General electrical design knowledge., • Working knowledge of cGMP, GAMP5, and regulatory requirements., • Technical writing experience such as: SOPs, Maintenance PMs, user requirement specs, vendor requests for proposal.