Senior Automation Engineer

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

Are you ready for a unique opportunity to contribute as a Process Control System (PCS) SME and Computerized System Validation (CSV) specialist at AGC Biologics? Do you have a manufacturing-centric mindset and are you eager to contribute your energy and talent in a highly engaged team?

We are looking for a Senior Automation Engineer to join our PCS & Application Engineering team in Søborg, Greater Copenhagen. In this role, you will contribute to the continued development, validation and support of automation and operational technology systems in a highly regulated biopharmaceutical manufacturing environment.

If you have experience with computerized systems such as DeltaV, Siemens PCS7, PLCs and SCADA, and can also perform CSV, we would love to hear from you.

Be part of our growing automation and validation activities

AGC Biologics CPH continues to enjoy great success, and we are expanding our portfolio of interesting projects in our state-of-the-art multipurpose production facility.

With this new production facility and a steadily increasing number of CSV and automation activities, we are looking for a strong and skilled CSV and automation SME who can contribute to driving CSV and establishing and supporting process automation and operational technology systems such as DeltaV, PCS7, PLCs and SCADA systems.

In this role, you will work across a range of activities, from validation and configuration to manufacturing support and problem solving. You will collaborate with stakeholders across the Copenhagen site as well as talented colleagues across the global AGC Biologics organization.

In this role, you will:

• 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.

The position offers interaction with different stakeholders both from the site in CPH and from talented colleagues across the global AGC network. You will be introduced to global biopharmaceutical companies and be an active player in their projects.

Join a team that values collaboration and knowledge sharing

You will be part of the PCS and Application Engineering team within the Equipment Engineering and Services department. The team currently consists of 11 highly qualified team members who work together across validation, qualification, automation and application engineering activities.

We have a fun and relaxed tone while maintaining high ambitions to deliver best-in-class validation, qualification and automation activities across the organization.

You will become part of an environment where knowledge sharing and collaboration are important, and where you will work closely with colleagues from different technical areas as well as stakeholders across the organization.

What we value most

For this role, we place particular emphasis on experience with DeltaV, PCS7 and CSV. Experience across these three areas will be highly relevant for the role and the team.

What will help you succeed?

• A relevant academic background and at least 5 years of relevant experience with GMP/Computer system validation and Automation & OT Systems.
• You have experience or interest in pharmaceutical Quality Management System, or you have taken part in GxP system validation and wish to grow in the role.
• Experience with Part 11, GAMP 5, Data integrity from a GxP environment, would be seen as a plus.
• 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.

Why build your career with AGC Biologics?

At AGC Biologics, you will join an international organization where science, technology and people come together to deliver life-changing therapies to patients around the world.

You will work in a highly regulated and technically advanced manufacturing environment, where automation, validation and operational technology play an important role in supporting safe and reliable production.

In this role, you will have the opportunity to:

• Work with complex automation and computerized systems in a GMP-regulated manufacturing environment.
• Collaborate with technical and business stakeholders across the Copenhagen site and global AGC Biologics organization.
• Contribute to projects involving leading global biopharmaceutical companies.
• Develop your expertise within automation, CSV and OT systems.
• Become part of a highly skilled and collaborative engineering team.

At AGC Biologics, we value collaboration, knowledge sharing and a positive working envi