Lead Automation Engineer II (Pharmaceutical)

Germer International - Pharmaceutical Recruiting; Lexington (KY); On-site; USD 120,000 - 160,000; Full time

Job summary

A pharmaceutical recruiting firm is seeking a Senior Automation Engineer II to design and implement automated systems. The ideal candidate should have at least 8 years of experience and strong knowledge of GAMP5 and cGMP standards. This full-time position offers a competitive salary ranging from $120,000 to $160,000. If you thrive in a fast-paced environment and enjoy improving automation processes, this is an excellent opportunity.

Qualifications

• 8+ years of related experience, or 6 years with a master’s, or 3 years with a PhD.
• Working knowledge of cGMP and regulatory requirements.
• Technical writing experience (SOPs, Maintenance PMs).

Responsibilities

• Design, develop, and implement automated systems.
• Analyze existing systems and create automation solutions.
• Lead installation and commissioning of new equipment.

Skills

Experience with GAMP5

Programming automation systems

Troubleshooting automation issues

General electrical design knowledge

Education

BS in engineering or related degree

Tools

PLCs

HMI hardware

Industrial sensors

Job description

Overview

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!

Base pay range: $120,000.00/yr - $160,000.00/yr

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.

Qualifications

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.
• 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.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function / Industries: Executive Search Services and Pharmaceutical Manufacturing