Job Description

Purpose / Summary

The Process Automation Engineer plays a critical role in designing, implementing, and supporting automated control systems that drive pharmaceutical manufacturing excellence. This position partners closely with cross-functional teams—including Manufacturing, Engineering, Maintenance, Quality, and IT—to ensure automation systems meet user needs, comply with regulatory standards, and reflect best practices in networking and computerized system design. The engineer serves as the key liaison between Operations and IT, ensuring computerized systems are properly maintained, integrated, and optimized for performance, reliability, and data integrity. By bridging technical expertise with collaborative execution, this role delivers scalable, compliant, and innovative automation solutions.

Key Responsibilities

Automation System Design & Support:

• Lead the design and specification of process automation systems in alignment with cGMP, GAMP, and other relevant standards.
• Develop and maintain: User Requirement Specifications (URS), Functional Design Specifications (FDS), Software Design Specifications (SDS), Hardware Design Specifications (HDS), Configuration Specifications (CS), etc.
• 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.

Commissioning, Validation & Compliance

• Collaborate with validation teams to ensure automation systems meet commissioning and qualification protocols.
• Support FAT/SAT activities and documentation for automated equipment and systems.
• Ensure automation systems comply with internal procedures, data integrity principles, and regulatory standards.

Cross-Functional Collaboration:

• 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.

Software Development & Optimization:

• 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.

Innovation & Continuous Improvement:

• 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.

Safety & Technical Support:

• 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 & Experience

• Education: Bachelor’s 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 med 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