Senior GMP Automation Engineer - SCADA & Validation

Comrise

Pennington (NJ)

On-site

USD 120,000 - 150,000

Full time

3 days ago

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Job summary

Comrise seeks a Senior Automation Engineer in New Jersey to support automation systems in a GMP-regulated biopharma environment, focusing on SCADA, PLCs, validation, and lifecycle management. You will collaborate with IT, Manufacturing, Quality Assurance, and external vendors to ensure reliability, compliance, and security of automation assets while developing SOPs and documentation.

This hands-on role requires 8+ years in industrial automation, expertise in AVEVA System Platform and FactoryTalk

Qualifications

Bachelor's degree required in a technical field.
8+ years in industrial automation or related area.
Hands-on with SCADA and automation systems.
Experience GMP-regulated biopharma environment.
Familiarity with validation and change control.
Knowledge of FDA 21 CFR Part 11 and related standards.

Responsibilities

Administer, maintain, and validate site automation systems (SCADA, PLCs, instruments).
Support lifecycle activities: installation, configuration, backup, upgrades, validation, retirement.
Develop and execute computer system validation documentation and reports.
Troubleshoot issues, root cause analysis, and implement corrective actions.
Manage change control, patches, and configuration changes.
Ensure system integrity, security, and availability across operations.
Provide guidance and training on automation procedures and compliance.