GxP Automation Engineer - GMP Controls & DCS/PLC

Biopharma Careers; Maryland; On-site; USD 90,000 - 130,000; Full time

Job summary

AbbVie is seeking an Automation Engineer to design, implement, and qualify automation and control IO for GMP facilities and labs. You will develop I&C design packages and support FAT/SFAT/SAT with CSV expectations.

Responsibilities include providing 24x7 on-site support, commissioning, change control, and ensuring 21 CFR Part11 compliance while driving continuous improvement across plant engineering and manufacturing networks.

Qualifications

• Bachelor's Degree in Engineering, science or closely related discipline preferred or equivalent technical experience with demonstrated competence.
• Working technical knowledge and application of concepts, practices, and procedures; able to work on problems of moderate scope.
• Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.

Responsibilities

• Support a Safe working environment by aligning with environmental health, safety & maintenance program practices, rules, and regulations.
• Provide day-to-day operations support for Upstream and Downstream Drug Substance manufacturing.
• Experience in change control, nonconformance, corrective & preventive actions, and Commissioning & Qualification activities.
• 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.
• 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 Part11 expectations.

Education

Bachelor's Degree in Engineering, science or closely related discipline

Tools

DeltaV

Rockwell PLC

Foxboro DCS

ISA 88

Job description

AbbVie is seeking an Automation Engineer to design, implement, and qualify automation and control IO for GMP facilities and labs. You will develop I&C design packages and support FAT/SFAT/SAT with CSV expectations.

Responsibilities include providing 24x7 on-site support, commissioning, change control, and ensuring 21 CFR Part11 compliance while driving continuous improvement across plant engineering and manufacturing networks.