DeltaV Automation Engineer

We are seeking experienced Automation Engineers with deep expertise in DeltaV 5.0 to support a high-impact initiative at a leading global medical device manufacturer. This role involves hands-on development and validation of automation systems within a regulated environment, with a strong emphasis on compliance, protocol execution, and cross-functional collaboration.

Key Responsibilities:

Design, configure, and support DeltaV 5.0 automation systems in a GMP-regulated setting

Lead and execute Computer System Validation (CSV) activities in alignment with FDA, GxP, and 21 CFR Part 11 standards

Author, review, and execute IQ/OQ/PQ validation protocols

Troubleshoot, maintain, and optimize automation systems for improved performance and compliance

Collaborate with cross-functional teams, including Quality, Validation, and Manufacturing Engineering

Develop and maintain comprehensive technical documentation and validation reports

Provide automation support during regulatory audits and inspections

Qualifications & Experience:

5+ years of experience in Automation Engineering within the medical device, pharmaceutical, or biotech industry

Strong working knowledge of DeltaV 5.0 (including configuration, optimization, and troubleshooting)

Proficiency in GMP, GxP, 21 CFR Part 11, and FDA validation requirements

Hands-on experience with CSV and protocol execution (IQ/OQ/PQ)

Familiarity with PLCs, SCADA systems, and related automation technologies

Excellent documentation and technical writing skills

Effective team player with the ability to work independently

Preferred Skills:

Experience with recipe management and batch processing in DeltaV

Understanding of risk assessments and regulatory compliance in automation environments

Knowledge of scripting or programming languages (optional but advantageous)