Senior Automation Engineer, CSV & DeltaV

AGC Biologics, Inc.; København; Hybrid; DKK 900,000 - 1,200,000; Full time

Job summary

AGC Biologics, Inc. in Copenhagen seeks a Senior Automation Engineer to specialize in Process Control System (PCS) and Computerized System Validation (CSV) within a regulated biopharma setting.

You will lead configuration and validation of DeltaV and PCS7, perform CSV testing, and support OT systems across the site and global AGC network, collaborating with diverse stakeholders to ensure compliant, reliable operations.

Qualifications

• 5+ years of experience with GMP/computer system validation and automation/OT systems.
• Experience with CSV testing and validation protocols.
• Ability to update procedures per regulatory guidelines (21 CFR Part 11, EU Annex 11).
• Strong communication across stakeholders.

Responsibilities

• Create batch and configuration for DeltaV and PCS7 systems.
• Perform CSV tests and compile validation reports.
• Oversee CSV activities from planning to completion.
• Maintain and update regulatory-compliant procedures and workflows.
• Provide manufacturing support for OT systems.

Skills

GMP/CSV experience

Automation & OT Systems

Cross-functional collaboration

Tools

DeltaV

PCS7

PLCs

SCADA

Job description

AGC Biologics, Inc. in Copenhagen seeks a Senior Automation Engineer to specialize in Process Control System (PCS) and Computerized System Validation (CSV) within a regulated biopharma setting.

You will lead configuration and validation of DeltaV and PCS7, perform CSV testing, and support OT systems across the site and global AGC network, collaborating with diverse stakeholders to ensure compliant, reliable operations.