Senior Automation & CSV Engineer (DeltaV/PCS7)

agcbio; København; On-site; DKK 780,000 - 980,000; Full time

Job summary

AGC Biologics, based in Søborg near Copenhagen, seeks a Senior Automation Engineer to strengthen the PCS and Application Engineering team. The role focuses on validation, configuration, and support of automation/OT systems in a GMP-regulated biopharmaceutical environment, with emphasis on DeltaV, PCS7, PLCs and SCADA.

You will work across validation, qualification, automation and application engineering activities, collaborating with stakeholders at the Copenhagen site and globally across AGC

Qualifications

• Minimum 5 years of relevant experience with GMP/Computer system validation and Automation & OT Systems.
• Experience with Part 11, GAMP 5, Data integrity from a GxP environment would be a plus.
• Strong understanding of GMP/CSV principles and regulatory compliance.
• Ability to communicate effectively with a broad audience of stakeholders.

Responsibilities

• Be responsible for creating batch and configuration of the DeltaV and PCS7 systems.
• Be responsible for performing CSV tests and protocols, compiling data and completing validation reports for implementation of new applications.
• Have oversight of different CSV activities from planning, execution to completion.
• Update and optimize current procedures in line with regulatory guidelines and compliance framework (21 CFR Part 11, EU Annex 11, ISA 88).
• Provide manufacturing support and problem solving of OT systems.

Skills

GMP/CSV validation

Cross-functional collaboration

Regulatory compliance

GxP knowledge

Education

Bachelor's degree in a relevant field

Tools

DeltaV

PCS7

PLC

SCADA

Job description

AGC Biologics, based in Søborg near Copenhagen, seeks a Senior Automation Engineer to strengthen the PCS and Application Engineering team. The role focuses on validation, configuration, and support of automation/OT systems in a GMP-regulated biopharmaceutical environment, with emphasis on DeltaV, PCS7, PLCs and SCADA.

You will work across validation, qualification, automation and application engineering activities, collaborating with stakeholders at the Copenhagen site and globally across AGC