(Senior) engineer for Upstream Process

Are you fascinated by cell culture, microbial fermentation processes and systems for commercial and clinical production? Would you like to be a trend setter in the selection of technologies to be implemented in state-of-the art mammalian facilities? Do you have a strong compliance mindset and would like to work with cGMP in relation to a variety of different biopharmaceutical upstream manufacturing equipment? In that case, you might be our new colleague!

 About the department:
You can look forward to becoming part of a dynamic and well-functioning team consisting of Automation, Process and Equipment Engineers. We thrive on professional challenges and work independently with great individual responsibility and a high level of commitment. We collaborate with diverse stakeholders in the organization at site and global levels including Production departments, MSAT, Process Development Departments, IT, Validation and QA as well as and with colleagues from our sister sites in the US, Japan, Italy and Germany. We enjoy contributing to a wide range of activities and projects within the organization. You will experience an enthusiastic working climate focused on quality, teamwork, and delivery. As an Equipment Responsible Engineer, you will play a critical role in supporting the production of mammalian upstream process equipment and ensuring reliable and robust operations. You will collaborate with cross-functional teams and stakeholders to support tech transfer activities, problem-solving initiatives, continuous improvement and the implementation of new technology.

Your primary responsibilities will be:

• Support tech transfer activities of new product introduction activities, collaborating closely with cross-functional teams to ensure a seamless process transfer.
• Provide on-the-floor presence and support after any critical process equipment changes, ensuring smooth operations and addressing any issues that arise promptly.
• Participate in systematic problem-solving activities, working closely with the other Engineering teams, as well as production departments, to identify and implement effective solutions.
• Stay up to date of industry technology trends in cell cultivation processes in biopharmaceutical production processes
• Participate and interact with internal and external stakeholders to select, install, and qualify hardware, software, and technology improvements throughout the process lifecycle, including designing, building, and testing.
• Collaborate with production owners to develop, prioritize, and manage projects aimed at enhancing operational robustness and cost efficiency.
• Drive, support, and perform assessments based on impact and effort to prioritize equipment changes and improvements.
• Support designing and optimization efforts for processing system throughout the process lifecycle, including specification (including URS and system documentation review), and testing (FAT, SAT, IOQ and commissioning activities).

Desired competencies:

• BSc, MSc or PhD degree in Chemical or Biochemical Engineering or a related field.
• Strong experience in working with mammalian upstream process equipment, cell cultivation processes (mammalian and/or microbial), and mass transfer and mixing in bioreactors design.
• Proven expertise in problem-solving methodologies and driving continuous improvement initiatives.
• Continuous learning mindset of the latest technology trends and instituting innovative thinking/mindset throughout the organization.
• Excellent collaboration and communication skills, with the ability to interact effectively with cross-functional teams and stakeholders.
• Strong focus on operational robustness, cost efficiency, and quality in everyday work and processes.
• Previous knowledge of equipment selection, specification, installation, qualification, and life cycle management practices such as URS, DQ, FAT, SAT, IQ, OQ or commissioning activities will be considered a plus
• Result and team-oriented person with a charming personality and humor.

In addition, you must thrive in a dynamic and fast-paced working environment where changes occur on short notice. The environment is dynamic and challenging at times, which requires finding solutions, delivering on promises, and giving our customers a positive experience. AGC has international customers, equipment suppliers and our company language is English. 

At AGC Biologics, you will get a unique opportunity working with a variety of different state of the art technologies among +40 different nationalities. This opens many doors for personal and professional development and for you to make a real difference towards patients, our customers, and your personal and professional growth. AGC offers an informal working