Sr. Automation Engineer

This role is responsible for maintaining, troubleshooting, optimizing, and improving automation systems that support safe, reliable, and compliant pharmaceutical manufacturing operations while supporting the planning, design, execution, commissioning, qualification, and startup of capital projects that enhance manufacturing capabilities, operational reliability, and regulatory compliance. The position works closely with Operations, Maintenance, Quality, Process Engineering, Project Engineering, contractors, and automation vendors to troubleshoot automation issues, implement system improvements, and successfully deliver capital projects.

Overview:

As a part of the Engineering Department, the Senior Automation Engineer provides technical leadership and engineering support for site automation systems and capital projects at the Cambrex Charles City manufacturing site. This role is responsible for maintaining, troubleshooting, optimizing, and improving automation systems that support safe, reliable, and compliant pharmaceutical manufacturing operations while supporting the planning, design, execution, commissioning, qualification, and startup of capital projects that enhance manufacturing capabilities, operational reliability, and regulatory compliance.

The Senior Automation Engineer serves as a key technical resource for Distributed Control Systems (DCS), process automation, equipment integration, and automation engineering solutions within a cGMP API manufacturing environment. The position works closely with Operations, Maintenance, Quality, Process Engineering, Project Engineering, contractors, and automation vendors to troubleshoot automation issues, implement system improvements, and successfully deliver capital projects.

The successful candidate will have strong hands-on experience with process automation systems, preferably Siemens PCS 7, along with experience supporting capital projects, equipment integration, commissioning, and startup activities in a regulated manufacturing environment.

Responsibilities:

• Serve as project lead or subject matter expert on site automation systems, including Distributed Control Systems (DCS), PLCs, HMIs, process control applications, and automation infrastructure.
• Troubleshoot complex automation issues impacting manufacturing operations and provide timely technical solutions.
• Support daily production activities by diagnosing control system issues, identifying root causes, and implementing corrective actions.
• Maintain automation system reliability through proactive monitoring, troubleshooting, preventive improvements, and lifecycle management.
• Develop and maintain automation standards, engineering specifications, procedures, and technical documentation.
• Support automation system backups, upgrades, configuration management, and obsolescence planning.
• Collaborate with cross-functional teams, including Engineering, Operations, IT, Maintenance, and Quality, to deliver integrated automation solutions.
• Review and provide technical approval for automation design packages, control narratives, and change control documentation.
• Identify opportunities for automation or advanced control to improve efficiency, reduce risk, and enhance product quality.
• Oversee vendor and integrator relationships, including scope of definition, project execution, and performance management.
• Ensure alignment with corporate IT/OT cybersecurity standards.

 

 

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

Qualifications / Skills::

• cGMP/FDA knowledge and/or experience highly beneficial.
• Minimum 7 - 10 years of industrial automation engineering experience in a cGMP pharmaceutical, biotechnology, chemical, or other process manufacturing environment.
• Hands-on experience with Distributed Control Systems (DCS), PLCs, HMIs, process control applications, and industrial automation systems.
• Experience with automation system troubleshooting, configuration changes, and system improvements in a manufacturing environment.
• Experience supporting capital projects, including automation scope development, design review, equipment integration, commissioning, and startup activities.
• Strong understanding of process control principles, including control loops, alarms, interlocks, sequences, and instrumentation interfaces.
• Ability to interpret and review engineering documentation, including control narratives, functional specifications, instrumentation drawings, and automation design packages.
• Experience working in a regulated manufacturing environment with knowledge of cGMP requirements preferred.
• Strong problem-solving, communication, and cross-functional collaboration skills.

Qualifications:

BS Electrical Engineering, Automation Engineering, Chemical Engineering, Computer Engineering highly preferred: other related fields will be considered with appropriate experience and knowledge.