Automation Engineer - Regulated Manufacturing & Validation

SlaterConsult; Raleigh (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

On-site role

Travel to client sites

Job summary

Confirm Automation & Validation is seeking a mid-level Automation Engineer to support process automation systems in a highly regulated environment. On-site with clients in Raleigh, NC, you will develop, maintain and optimize automation solutions ensuring regulatory compliance.

Responsibilities include designing and maintaining DCS/PLC/SCADA systems, validating software/hardware, and preparing technical documentation. Candidate should have 2–5 years in pharma/biotech and DeltaV experience.

Qualifications

• BS/MS in Engineering or equivalent required.
• 2–5 years in a regulated industry (pharma, biotech, etc.).
• Hands-on DeltaV experience (Emerson DCS).
• Knowledge of 21 CFR Part 11, EU Annex 11.
• Experience with Rockwell, Siemens, OSI PI Historian, SCADA and PLCs.
• Troubleshooting in a 24/7 cGMP manufacturing environment.
• Strong problem-solving and consultative skills.

Responsibilities

• Provide on-site automation engineering support and troubleshooting.
• Design, configure, implement and maintain manufacturing automation systems (DCS, PLC, SCADA, and Historians).
• Ensure compliance with FDA, cGMP, ISA88, GAMP, ASTM E2500 and other industry standards.
• Work collaboratively with clients, vendors and project teams.
• Develop and execute test cases for system validation.
• Prepare technical documentation, including hardware/software design specs.

Skills

Troubleshooting

Consultative role

Regulated industry experience

On-site collaboration

Education

BS/MS in Engineering or equivalent

Tools

DeltaV (Emerson DCS)

Rockwell

Siemens

OSI PI Historian

SCADA

PLCs

Job description

Confirm Automation & Validation is seeking a mid-level Automation Engineer to support process automation systems in a highly regulated environment. On-site with clients in Raleigh, NC, you will develop, maintain and optimize automation solutions ensuring regulatory compliance.

Responsibilities include designing and maintaining DCS/PLC/SCADA systems, validating software/hardware, and preparing technical documentation. Candidate should have 2–5 years in pharma/biotech and DeltaV experience.