Senior Automation Engineer: CSV & OT (DeltaV/PCS7)

AGC Biologics; København; On-site; DKK 900,000 - 1,100,000; Full time

Job summary

AGC Biologics is seeking a Senior Automation Engineer to join the PCS & Application Engineering team in Søborg, Greater Copenhagen. You will contribute to automation validation and support of OT systems in a highly regulated biopharmaceutical manufacturing environment.

You will work on configuring DeltaV/PCS7, perform CSV tests, and ensure compliance with 21 CFR Part 11, EU Annex 11, ISA 88. The role collaborates with stakeholders across the Copenhagen site and AGC Biologics network.

Qualifications

• A relevant academic background and at least 5 years of GMP/Computer system validation and Automation & OT Systems.
• Experience or interest in pharmaceutical Quality Management System, or part in GxP system validation.
• Experience with Part 11, GAMP 5, Data integrity from a GxP environment.
• Make things happen in a context of high complexity.
• Good team player, open minded and result orientated.
• Ability to effectively communicate with a broad audience of stakeholders.
• Bring positive energy to the team.

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 when needed of regulatory guidelines and compliance framework, such as 21 CFR Part 11, EU Annex 11, ISA 88 etc.
• Provide manufacturing support and problem solving of operational technology systems.

Skills

GMP/CSV knowledge

Regulatory compliance

Effective communication

Team player

Problem solving

Education

Bachelor's degree in Engineering or related field

Tools

DeltaV

PCS7

SCADA

PLCs

Job description

AGC Biologics is seeking a Senior Automation Engineer to join the PCS & Application Engineering team in Søborg, Greater Copenhagen. You will contribute to automation validation and support of OT systems in a highly regulated biopharmaceutical manufacturing environment.

You will work on configuring DeltaV/PCS7, perform CSV tests, and ensure compliance with 21 CFR Part 11, EU Annex 11, ISA 88. The role collaborates with stakeholders across the Copenhagen site and AGC Biologics network.