Do you want to be part of a new state-of-the art mammalian facility since its very beginning? Would you like to take ownership for implementing, and qualifying brand-new equipment? Do you have a flair for at-line analytical and supporting equipment (cell counters, cell-culture analyzers, portable pH-meters, portable conductivity-meters, filter integrity testers, etc.)? Do you have a strong compliance mindset and would like to work with cGMP in relation to a variety of different biopharmaceutical manufacturing equipment? In that case, this position is something for you!
The Process Engineering Department is looking for a Manufacturing Equipment Responsible Engineer to assist AGC Biologics in our continuous growth. You will become part of an agile department of highly dedicated engineers and technicians that work closely with external customers and internal stakeholders for acquisition, installation, commissioning and qualification of manufacturing equipment at our facilities in Copenhagen.
You will cooperate closely with the other departments at AGC Biologics in CPH and with colleagues from our sister sites in the US, Japan, Italy and Germany to ensure that all quality-related activities are carried out LEAN effectively and in compliance cGMP. The Process Engineering team has a positive and proactive profile is committed, strongly goal-oriented team, professional and friendly collaboration.
Your key responsibilities will be to:
- Prepare URS and consequent request for an offer to possible suppliers and technical comparison in order to make the most suitable choice in terms of compliance with requirements, times and costs.
- Work closely with suppliers to follow project development, timing control, and review / approval of received documentation
- Supervise and coordinate the installation, management of supplier planning, management of the open point list up to commissioning, with following support to the Equipment Validation and Computerized Systems Validation qualification final phases
- Collaborate with key departments and personnel in technology transfer projects
- Develop implementation cost models for project development and implementation
- Optimize processes and procedures to collaboratively create manufacturing efficiency, process robustness, reduced costs and facility reliability
- Prepare and maintain training materials and operational documentation
- Communicate progress, status, and issues to stakeholders and upper management
We imagine that you have:
- A scientific education (BSc or MSc) in (Civil) Engineering, Marine Engineering (Maskinmester), Bioprocessing, Biology or related discipline
- At least two years of working experience within pharma is preferred
- A holistic understanding of manufacturing bioprocesses and facilities for cGMP manufacturing of biological intermediates and APIs for mammalian and microbial bulk production processes,
- High level of initiative in troubleshooting and accurate data analysis.
- Strong leadership, organizational planning and project management skills, is required to work with multi-disciplinary teams.
- Ability to balance many tasks simultaneously
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 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 both patients, customers and your own 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.
For agencies, please contact our Talent Acquisition team at firstname.lastname@example.org
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.