(senior) automation engineer

Regio:
Leiden
 
Functieomschrijving

About Batavia Biomanufacturing

At Batavia Biomanufacturing we are taking an ambitious next step: establishing a brand-new, high-end manufacturing facility in Leiden. This facility is designed according to the latest standards and offers the space to develop and produce advanced vaccines, viral vectors, and other biomedical products.

Our mission is clear: to accelerate and enhance the development and manufacturing of life-saving biotechnological products. If you believe in innovation, quality, and making an impact, this is your opportunity to help build the success of Batavia Biomanufacturing.


Role & Job Purpose


Responsible for ensuring reliable and compliant operation of automated and computerized systems across Batavia Biosciences and Batavia Biomanufacturing. The role includes the design, commissioning, and lifecycle management of automation solutions, as well as providing first- and second-line technical support. By combining strong troubleshooting skills, quality focus, and collaboration with cross-functional teams, the Automation Engineer ensures system robustness, user satisfaction, and continuous improvement in line with GxP and regulatory requirements.


General skills & responsibilities


Competencies


Communication: Clear and concise communication in a challenging environment.

Ownership: At Batavia, our goal is to set a high quality standard for our manufacturing facility. We want to be the best with state-of-the-art equipment and in-house knowledge about systems and processes. You feel responsible for the quality and technical state of the department’s deliverables.


Quality minded: Quality is key in our organization. Within the Automation department, we commission the automated systems together with the vendor and ensure a system is robust and according to our standards. We stand by our work and we are open and honest about successes and failures. Successes are examples of how it’s done, failures are opportunities to learn and improve together.

Solution-oriented: We focus on providing solutions. Whether it’s a difficult question from an operator, a technical challenge during commissioning or a breakdown of a system with an unknown cause. We investigate the problem, suggest proper solutions and implement a solution in accordance with procedures.


Troubleshooting: When a system has a breakdown, deviation or malfunction, we investigate the root cause and find a solution. Investigating means interviewing users, researching the system and testing to find the issue. When we have found the issue, we solve it and try to prevent it from happening again. We document these activities to improve and reduce breakdown durations in the future.


Collaboration: Working effectively with cross-functional teams including IT, EMF, QA, and operations is essential for successful automation projects.

Analytical Thinking: Strong analytical skills are required to diagnose issues, validate systems, and optimize performance.


Responsibilities


Batavia’s OT department is responsible for:

- Design & commissioning of computerized systems in accordance with our standards (Project phase)

- Computerized System Management (Operational Phase):

o User Management

o Data Management

o Asset Management

o Incident Management

o Security

o Backup & Recovery

o Lifecycle Management

o Maintenance

o Continuous Improvement

- 1st and 2nd line technical support

o Questions from users

o Bugfixing

o Breakdowns


Professional Requirements


  • 3+ (Medior) or 6+ (Senior) years of relevant work experience
  • Several years of work experience in a highly regulated work environment. Pharma/biotech experience is a plus.
  • Ideally advanced knowledge of GMP Annex 11 / FDA 21 CFR Part 11
  • Bachelor’s degree or equivalent experience in Automation or other relevant technical study (e.g., hands-on experience in automation systems, certifications, or relevant project work)
  • Fluent in Dutch and/or English (verbal and written)


Additional experience (advantage):

o Experience with TIA Portal

o Experience with SQL databases

o Experience with Microsoft Active Directory

o User Management

o Policy Management

o GAMP5 certified

o Experience in networks

o Experience in document writing (SOPs, Work Instructions)

o Experience in planning/coordinating maintenance activities