The Principal I&C Engineer leads design, implementation, and qualification of automation and controls IO layer for GMP facilities and labs, bridging process, IT/OT, and quality to deliver compliant, reliable operations. They develop I&C design packages, configure DCS/PLC systems IO (often FoxBoro, DeltaV), and support FAT/SFAT/SAT through turnover in line with CSV expectations. This role provides technical leadership, ensures compliance with applicable codes and standards, supports project execution and running facility. The Engineer will design, develop, and deliver innovative solutions enabling the advancement of AbbVie’s Clinical and Commercial Drug Substance manufacturing processes.

Responsibilities

• Support a Safe working environment by aligning with all pertinent environmental health, safety & maintenance program practices, rules, and regulations.
• Provide technical leadership for Day-to-day operational shift support for Upstream and Downstream Drug Substance manufacturing.
• Experience in change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities.
• Experience in various instrumentation with the following product platforms: Rockwell PLC Platform, Emerson DeltaV
• Day-to-day Operational Support: 24 x 7 Onsite/On Call: Rotational Support
• Troubleshooting support to Mfg.
• Lead FEED and detailed design for I&C scope; define I/O allocations, network topologies, and panel architectures aligned to process and facility constraints.
• Produce complete I&C design packages (enclosure details, panel layout/BOM, terminal block details, power distribution/grounding, I/O wiring, network integration details).
• Specify/oversee fabrication of control panels and field integration and manage vendor E&I scope.
• Configure, review and test DCS/PLC I/O layer and relevant applications; often DeltaV with ISA 88 batch (CM/EM classes, recipes, graphics), including SFAT/FAT.
• Troubleshoot instrumentation and control system issues, optimizing control strategies for safety, reliability and efficiency.
• Plan and execute SAT and support OQ/commissioning: loop checks, calibration coordination, punch-list closure, turnover documentation.
• Execute in a GxP manner with full traceability and change control (e.g., VCAT/audit trail), in alignment with CSV practices and 21 CFR Part 11 expectations.
• Being responsible for driving continuous improvement in partnership with Plant Engineering, Maintenance, Manufacturing, Process engineering and OPex to drive operational efficiencies.
• Responsible for collaborating within the AbbVie network to learn, implement and share Continuous improvement opportunities within the Drug Product manufacturing AbbVie Global network.
• Demonstrated understanding of project life cycles is preferred- Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations. Responsible for developing & maintaining Engineering Specifications, documents, drawings, and - Standard Operational Procedures (SOP) including Administrative SOPs and Job Aids.
• As a System SME, be accountable and responsible to provide the necessary support during the internal and external regulatory audits.