Automation Engineer (onsite role in MA)

Role Summary

Automation Engineer role onsite in Massachusetts focusing on developing automation technologies and manufacturing control systems to improve site productivity, quality, and safety in drug product manufacturing. Requires strong background in engineering, configuration, programming, installation, commissioning, maintenance, and troubleshooting of process controls, automation, electrical devices, and field instrumentation technologies.

Responsibilities

• Support a safe working environment by aligning with environmental health, safety, and maintenance program practices and regulations.
• Understand cGMP processing with change control, nonconformance, corrective and preventative actions, and commissioning and qualification activities.
• Work with product platforms such as Rockwell PLC and Emerson DeltaV.
• Provide day-to-day operational support including 24 x 7 onsite/on-call rotational support and troubleshooting for manufacturing.
• Be a knowledgeable SME for upstream and downstream unit operations; perform troubleshooting with Plant Engineering & Maintenance to enhance uptime and reliability of automation systems.
• Drive continuous improvement in partnership with Plant Engineering, Maintenance, Manufacturing, Process Engineering, and OPex to improve operational efficiencies.
• Collaborate within the AbbVie network to learn, implement, and share continuous improvement opportunities across the global drug product manufacturing network.
• Apply automation engineering principles in design, specification, construction, startup, commissioning, and qualification of process equipment and systems for capital projects; understand project life cycles.
• Develop and maintain engineering specifications, documents, drawings, SOPs, Administrative SOPs, and Job Aids.
• Provide user requirements to OEMs/system integrators for PLC, HMI, SCADA, and MES (e.g., POMS) for process control applications and batch reporting.
• Ensure compliance with industry standards such as 21 CFR Part 11 (data integrity, user security, disaster recovery, data backup & restore).
• Communicate effectively with stakeholders across the organization.

Qualifications

• Bachelor‚Äôs degree in Mechanical Engineering, Electrical Engineering, Computer Science, or related field.
• 2‚Äì4 years‚Äô experience developing and maintaining automation software, equipment, and PLC systems in manufacturing; AI/ML experience and new technology development for product introductions is a plus.
• Direct experience with system development and validation, including DS/FS/URS and risk-based validation strategies, and validation protocol development and execution.
• Knowledge of 21 CFR Part 11 for automated systems in pharma/medical devices.
• Strong problem-solving skills and ability to develop and implement innovative solutions.

Skills

• Proficiency with PLC, HMI, SCADA, and MES platforms; experience with POMS or similar MES is desirable.
• Experience with Rockwell PLC and Emerson DeltaV platforms.
• Strong understanding of cGMP, change control, deviation management, and validation.
• Excellent communication and collaboration abilities across cross-functional teams.

Education

• Bachelor‚Äôs degree as listed above.

Additional Requirements

• Onsite role in Massachusetts; travel not specified as a primary requirement.
• Legal eligibility to work in the U.S. and comply with site-specific safety and regulatory requirements.