Automation Engineer

Job Summary:

Syngene International is seeking a skilled Automation Engineer to support our Engineering and Maintenance team at the Bayview facility located in Baltimore, Maryland. This critical role is responsible for the implementation, maintenance, and optimization of site automation and control systems, ensuring reliable and compliant operation of manufacturing, laboratory, and facility processes. The position requires strict adherence to regulatory requirements, data integrity standards, and industry best practices within FDA and USDA regulated industries.

The successful candidate will bring strong technical expertise in automation and control systems, demonstrate effective problem-solving capabilities, and collaborate closely with cross-functional teams to resolve complex system challenges. This individual will play a key role in managing automation-related projects, supporting system lifecycle activities, interfacing with vendors, and ensuring alignment of automation solutions with evolving business and operational needs.

Key Responsibilities:

• Administer and maintain Operational Technology (OT) systems, including user account management, system configurations, network connectivity, backups, and version control of automation applications and code.
• Plan, execute, and oversee automation and control system projects, ensuring delivery aligns with scope, schedule, budget, and regulatory requirements.
• Provide technical support for routine and corrective maintenance of automated systems and equipment, ensuring regulatory compliance, maximum uptime and reliable performance of automated systems.
• Support commissioning, validation, and qualification (IQ/OQ/PQ) activities for automated systems and computerized equipment in compliance with GMP and site procedures.
• Support site and corporate data integrity initiatives and maintaining compliant automation systems aligned with regulatory expectations (e.g., 21 CFR Part 11, ALCOA+ principles, various industry standards).
• Manage lifecycle activities for automation systems, including upgrades, migrations, and obsolescence management, while coordinating with internal stakeholders, vendors, OEMs, and IT.
• Identify and implement improvements to automation hardware and software to enhance system regulatory compliance, reliability, efficiency, and maintainability.
• Work closely with external vendors, Engineering, IT, Quality, and Manufacturing teams to resolve issues, implement solutions, and align automation systems with business needs

Technical Experience:

• Demonstrated hands-on experience with automated process systems and equipment in a regulated manufacturing environment.
• Proven experience and expertise in Rockwell Automation platforms, including PLCs (ControlLogix/CompactLogix), FactoryTalk, PanelView, and associated hardware/software.
• Working knowledge of SCADA/MES visualization platforms, including Inductive Automation Ignition and/or AVEVA Wonderware.
• Experience operating within regulated environments, with solid understanding of cGMP practices and 21 CFR Part 11 compliance (electronic records/signatures).
• Familiarity with Building Automation Systems (BAS), with preference for experience in Siemens Desigo and/or Apogee platforms.
• Working knowledge of instrumentation and control systems, including sensors, transmitters, control valves, and loop tuning.
• Understanding of biotechnology processes and equipment is a plus.

Qualifications:

• Bachelor’s degree in Chemical, Electrical or Mechanical Engineering preferred.
• Minimum of 5+ years of demonstrable experience in an automation-focused field.
• Exceptional problem-solving and organizational skills.
• Excellent interpersonal and communication skills.

Soft Skills:

• Strategic thinking and planning
• Strong communication and interpersonal abilities
• Ability to work under pressure and manage multiple priorities

Working Conditions:

• Availability for on-call support or off-hours maintenance
• Occasional cleanroom gowning is required for this role