Process Automation Engineer

Role Summary

The Process Automation Engineer designs, implements, and supports automated control systems for pharmaceutical manufacturing. Partners with cross-functional teams to ensure automation systems meet user needs, regulatory standards, and best practices in networking and computerized system design. Serves as the liaison between Operations and IT to maintain, integrate, and optimize systems for performance, reliability, and data integrity.

Responsibilities

• Lead the design and specification of process automation systems in alignment with cGMP, GAMP, and other relevant standards.
• Develop and maintain: URS, FDS, SDS, HDS, CS, and related documents.
• Troubleshoot and resolve issues related to automation hardware and software in manufacturing environments.
• Update control system software to accommodate process changes, device integration, and performance enhancements.
• Collaborate with validation teams to ensure commissioning and qualification protocols are met.
• Support FAT/SAT activities and documentation for automated equipment and systems.
• Ensure automation systems comply with internal procedures, data integrity principles, and regulatory standards.
• Partner with Manufacturing, Engineering, Maintenance, Quality, and IT to ensure systems are user-centric, compliant, and aligned with operational goals.
• Serve as the primary liaison between Operations and IT, ensuring computerized systems are properly maintained and optimized.
• Manage relationships with equipment vendors to ensure timely delivery, technical alignment, and quality performance.
• Coordinate with systems integrators to execute complex automation projects, ensuring seamless integration and scalability.
• Lead software upgrade projects across control platforms, ensuring minimal disruption and full compliance with validation requirements.
• Develop and deploy software bug fixes, enhancements, and performance improvements across automation platforms.
• Maintain and enhance automation support tools such as data historians and software revision control systems.
• Identify and implement high-value, achievable improvements to automation systems and manufacturing processes.
• Evaluate and integrate new data management tools and technologies to improve system performance and data accessibility.
• Contribute to capital project execution, including design reviews, installation oversight, and system integration.
• Promote safety awareness and ensure proper use of protective equipment in all engineering activities.
• Provide technical support to metrology and calibration teams to deploy assets with effective process ranges and calibration job plans.
• Support manufacturing, engineering and facilities with equipment troubleshooting, at times off-hours, to reduce maintenance time and increase process reliability.

Qualifications

• Education: Bachelor‚Äôs degree in Automation Engineering, Computer Science Engineering, Mechanical Engineering, Electrical Engineering, or equivalent experience.
• Experience: Minimum of 5 years in automation engineering within a manufacturing environment, preferably in the medical device and/or biopharmaceutical industry.
• Technical Skills: Proficiency with automation platforms such as Rockwell Automation, Ignition, Siemens, Wonderware, and Modicon. Experience with Johnson Controls (JCI) Building Management Systems is a plus.
• Software Expertise: Proven ability to lead software upgrade projects, implement bug fixes, and optimize system performance.
• Project Leadership: Track record of successfully leading and supporting capital and automation projects from concept through execution.
• Communication: Strong verbal and written communication skills, with the ability to collaborate effectively across departments and with external partners.
• Regulatory Knowledge: Familiarity with cGMP, GAMP, and data integrity principles, with a strong understanding of compliance in regulated environments.
• Collaboration: Experience managing vendor relationships and partnering with systems integrators on complex automation initiatives.
• Systems Knowledge: Solid understanding of networking, computerized systems, and data management tools used in manufacturing environments.

Skills

• Automation platform proficiency
• Regulatory compliance and data integrity
• Vendor and systems integrator management
• Project management and execution
• Cross-functional collaboration
• Software development and validation practices

Education

• Bachelor‚Äôs degree in relevant engineering or computer science field

Additional Requirements

• None beyond those listed