Job Description

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.

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