Senior Automation Engineer

at  AGC Biologics

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
Senior Automation Engineer
Supporting Ongoing Operation and Modification Projects
Would you like to be part of AGC Biologics’ growing success?
At AGC Biologics A/S, we specialize in the development and GMP manufacturing of APIs for commercial products and products in all clinical phases. As a client-centric CDMO, our primary focus is on fostering partnerships with our clients, collaborating closely with them every step of the way.
We are currently seeking a Senior Automation Engineer to bolster our automation systems for ongoing operations and various rebuild projects. As we prepare to operate two manufacturing facilities in 2024, including our new EUR 160 million Mammalian Manufacturing Facility, your role will be instrumental in ensuring smooth operations.
The Department
You will join the Plant Engineering department, which oversees the operation of utility systems, maintenance, calibration, and technical projects across our facilities. Comprising approximately 45 employees, including managers, engineers, project managers, compliance specialists, and technicians, this department is integral to our operations.
The Position
In this role, you will be responsible for ensuring AGC requirements are met for our automation systems, encompassing life cycle management, changes, and project activities. Primarily focused on our GMP automation systems (SCADA and FMS), you will also provide support for other systems as needed based on your expertise and business requirements. Our primary GMP automation systems include SCADA process control systems for various utility systems and two distinct FMS systems for monitoring critical parameters in both facilities.

Your responsibilities will include:

• Ensuring compliance with company and site procedures and policies.
• Overseeing the safe and effective implementation of changes and project activities in accordance with industry standards and regulatory requirements.
• Presenting system documentation during audits and inspections on a monthly basis.
• Providing technical leadership in handling deviations, CAPAs, and change requests.
• Developing and updating procedures and conducting training for organizational staff.
• Collaborating effectively with internal and external stakeholders.
• Assisting in troubleshooting activities requiring advanced technical expertise.

Requirements for this role include:

• A relevant Engineering degree.
• 5+ years of experience in the biopharmaceutical industry, with a strong background in GMP environments.
• Experience in maintenance, troubleshooting, and compliant operation of automation systems.
• Experience in implementing changes and project activities, including testing and qualification.
• Hands-on experience with SCADA and FMS systems. Proficiency in writing standard operating procedures and conducting training.
• Ability to work well under pressure and adapt to changing demands.
• Excellent communication skills, both written and verbal, with fluency in English; proficiency in Danish is an advantage.
• Solid technical knowledge of pharmaceutical facilities.
• Understanding of the qualification process for pharmaceutical manufacturing facilities.

How to Apply
Interested candidates are encouraged to submit their applications at their earliest convenience, as we review applications upon receipt and conduct interviews accordingly.
For further information about the position, please contact Jesper Sandholm Hansen, Senior Director in Plant Engineering, at +45 25578027.
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on
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AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

Your responsibilities will include:

• Ensuring compliance with company and site procedures and policies.
• Overseeing the safe and effective implementation of changes and project activities in accordance with industry standards and regulatory requirements.
• Presenting system documentation during audits and inspections on a monthly basis.
• Providing technical leadership in handling deviations, CAPAs, and change requests.
• Developing and updating procedures and conducting training for organizational staff.
• Collaborating effectively with internal and external stakeholders.
• Assisting in troubleshooting activities requiring advanced technical expertise

Requirements for this role include:

• A relevant Engineering degree.
• 5+ years of experience in the biopharmaceutical industry, with a strong background in GMP environments.
• Experience in maintenance, troubleshooting, and compliant operation of automation systems.
• Experience in implementing changes and project activities, including testing and qualification.
• Hands-on experience with SCADA and FMS systems. Proficiency in writing standard operating procedures and conducting training.
• Ability to work well under pressure and adapt to changing demands.
• Excellent communication skills, both written and verbal, with fluency in English; proficiency in Danish is an advantage.
• Solid technical knowledge of pharmaceutical facilities.
• Understanding of the qualification process for pharmaceutical manufacturing facilities