Senior Automation Engineer

Harba; Indianapolis (IN); On-site; USD 110,000 - 140,000; Full time

Job summary

Harba is seeking an experienced Automation Engineer in Indianapolis to lead design, configuration, and troubleshooting of automated control systems across manufacturing operations. You will own lifecycle activities from specification to long-term support and drive validation with cross-functional teams.

You will support FDA/ISO inspections as automation SME, author specs and diagrams, and mentor junior engineers while coordinating MES and plant IT/OT integrations.

Qualifications

• Degree in Engineering (Electrical, Mechanical, Chemical, Controls/Automation, Computer Engineering, or related).
• 5+ years automation/controls experience in pharma/biotech/medical device manufacturing.
• Hands-on PLC programming and SCADA/HMI design experience.
• Experience leading commissioning, qualification, and validation activities.
• Solid knowledge of cGMP, FDA regs, and 21 CFR Part 11.
• Experience supporting FDA/regulatory inspections as automation SME.
• Strong written and verbal communication; able to influence stakeholders.

Responsibilities

• Lead design, configuration, and troubleshooting of automated control systems across manufacturing operations.
• Own control system lifecycle activities from specification to long-term support.
• Lead IQ/OQ/PQ validation with Validation and Quality teams.
• Support FDA/ISO inspections as automation SME.
• Create and approve functional specs, P&IDs, and system architecture docs.
• Coordinate integration between automation systems, MES, and plant IT/OT.
• Plan FAT/SAT and manage change control and revalidation scope.
• Mentor junior automation engineers on design standards and troubleshooting.

Skills

PLC programming

Commissioning & qualification

Regulatory knowledge

Cross-functional communication

Project management

Production floor experience

Education

Bachelor's degree in Engineering

Tools

RSLogix

FactoryTalk

WinCC

Allen-Bradley

Siemens

Job description

Responsibilities

• Lead design, configuration, and troubleshooting of automated control systems (PLCs, SCADA, DCS, HMIs) across manufacturing operations
• Own control system lifecycle activities, including specification, commissioning, qualification, and long-term support of automation platforms
• Lead validation and qualification (IQ/OQ/PQ) of new and modified automated systems in partnership with Validation and Quality teams
• Serve as automation subject matter expert (SME) during internal audits and external regulatory inspections (FDA, ISO), including front room/back room support
• Author and approve functional specifications, control narratives, P&IDs, and system architecture documentation for automation projects
• Lead integration efforts between automated systems, Manufacturing Execution Systems (MES), data historians, and broader plant IT/OT infrastructure
• Lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) planning and execution for new automation equipment and control systems
• Drive change control processes for automation modifications, software upgrades, and system migrations, ensuring appropriate risk assessment and revalidation scope
• Lead root cause investigations for automation-related deviations, downtime events, and control system failures
• Mentor and provide technical guidance to junior automation engineers on control system design, programming standards, and troubleshooting
• Partner with Manufacturing, Process Engineering, Validation, and IT/OT teams to align automation project timelines with production and capital project schedules
• Drive continuous improvement initiatives to enhance system reliability, cybersecurity posture, and process control optimization
• Manage vendor and contractor relationships for automation system integrators, ensuring quality and timeline adherence on capital projects
• Ensure all automation systems and documentation comply with FDA regulations, cGMP, 21 CFR Part 11, and internal quality standards
• Support alarm management strategy, data historian configuration, and control system security/access administration at a program level

Qualifications

Required:

• Bachelor's degree in Engineering (Electrical, Mechanical, Chemical, Controls/Automation, Computer Engineering, or related field)
• 5+ years of automation/controls engineering experience in pharmaceutical, biotech, or medical device manufacturing
• Strong hands‑on experience with PLC programming (e.g., Allen‑Bradley/Rockwell, Siemens) and SCADA/HMI system design
• Demonstrated experience leading commissioning, qualification, and validation of automated systems (IQ/OQ/PQ)
• Strong working knowledge of cGMP, FDA regulations, and 21 CFR Part 11 as applied to automated/computerized systems
• Experience supporting or leading FDA/regulatory inspections as an automation SME
• Proficiency with control system software (RSLogix, FactoryTalk, WinCC, or similar) and industrial networking fundamentals
• Excellent written and verbal communication skills, with ability to influence cross‑functional stakeholders and present to leadership
• Proven ability to manage multiple automation projects simultaneously, including budgets, timelines, and vendor coordination
• Willingness to work on the production floor, including gowning/cleanroom protocols as required