*Equipment Responsible Engineer for Downstream Process
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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, Equipment and Facility Validation and QA as well as and with colleagues from our sister sites in the US, Japan, Italy and Germany. As an Equipment Responsible Engineer, you will play a critical role in supporting the production department and ensuring reliable and robust operations and compliant equipment onboarding. You will collaborate with cross-functional teams and stakeholders to support tech transfer activities, problem-solving initiatives, continuous improvement, and the implementation of new technologies.
Your primary responsibilities will be:
- Provide on-the-floor presence and support after any critical process equipment changes, ensuring smooth operations and addressing any issues that arise promptly.
- Support tech transfer activities of new product introduction activities, collaborating closely with cross-functional teams to ensure a seamless process transfer.
- 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 downstream processes in biopharmaceutical production processes
- Participate and interact with stakeholders to select, install, and qualify hardware, software, and technology improvements throughout the process lifecycle, including specification (including URS and system documentation review), and testing (FAT, SAT, IOQ and commissioning activities).
- Collaborate with production owners to develop, prioritize, and manage projects aimed at enhancing operational robustness and cost efficiency.
- Establish life cycle management processes for equipment, ensuring proper maintenance, calibration, and replacement strategies are in place.
- Drive, support, and perform assessments based on impact and effort to prioritize equipment changes and improvements.
Desired Competencies:
- BSc, MSc or PhD degree in Chemical or Biochemical Engineering or a related field.
- 2+ years of experience in working with biopharmaceutical process equipment, preferentially with single-use technology and recovery and purification processing steps such as chromatography, filtration (such as TFF, UF/DF) and centrifugation.
- 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.
- Knowledge of equipment selection, specification, installation, qualification, and life cycle management practices such as URS, DQ, FAT, SAT, IQ, OQ and commissioning activities
- 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. It is therefore a required ability that communication in both written and spoken English is fluent.
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 environment, characterized by the fact that we think it is fun to go to work. We respect each other and our differences. AGC employees are flexible and take pride in working together to achieve goals as one team.
Applications are screened on an ongoing basis. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation for applying to this position.
Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 14.11.2023, men kan have været deaktiveret og genaktiveret igen.
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