GMP Engineer, Team Lead

GMP Engineer, Team Lead (f/m/d) 100%. Hørsholm, DK

Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.

Create your own future as:

GMP Engineer, Team Lead (f/m/d) 100%.

For our Engineering/Facility Team supporting our GMP DS Manufacturing Facility based in Hørsholm Denmark, we are looking for a full-time GMP Engineer, preferably with management skills and relevant experience running engineering activities in a GMP environment.

If you would like to be a part of the journey to introduce LBP to the pharmaceutical market – if you are ready for a challenge and the possibility to learn more and make a different – this is the right position for you.

My main tasks will be…

Be the Team Lead in the Engineering/Facility Team. I will be working in a team of passionate and highly dedicated people in an informal and dynamic work environment. As part of the role I will be communicating with essential functions in the production team, QA and communication with externals. It requires from me to be a self-driven personality with the passion to take responsibility and move projects forward. I will have the responsibility of coordinating the daily tasks within the team:

  • I will be responsible for planning, scheduling and coordination of maintenance and calibration activities
  • I will create and maintain equipment specific maintenance plans and data sheets
  • I will be working in close collaboration with an Engineering team to ensure the facility, utilities and equipment are in a compliant state
  • I will perform yearly reporting on equipment
  • I am able to perform and drive systematic problem solving
  • I will be supporting our Production Team with optimizing the process
  • I will be involved in or responsible for production related activities such as; Writing production related documents, CR, Deviations etc.

Facility

  • Access control
  • Periodic EM monitoring
  • PTW monitoring & sampling
  • Annual trending
  • Cleaning & gowning
  • Training

I bring with me…

  • GMP Engineering background, with solid experience working in this field
  • It will be an advantage if you have experience working in the pharma industry
  • You are able to navigate and work within the requirements for compliance (CR, Deviations, CAPA etc.)
  • You have previous experience in management or have a good profile for filling this task
  • You enjoy being involved in the process and participating in the facility
  • You work self-driven and thrive in an environment where a lot is ongoing at the same time
  • You are a person who is eager to learn, a good team player and able to handle a lot of different tasks at the same time
  • Being agile, highly motivated, and dynamic drive is needed in this fast-paced environment
  • Very good communication skills in English (verbal and written)
  • I feel comfortable to work also outside my area of competences

My reasons for choosing Bacthera…

  • ​​​​​​​Innovative and fast-growing start-up company with short decision-making processes
  • Interesting and diversified tasks

This is the opportunity to be part of a fast-growing start-up company, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting to you, we are looking forward to hear more about you.

Please send all your documents (motivation letter, CV, letter of references, diplomas, etc.) to Ms. Sandra Gamboni, Global Head of HR, hr@bacthera.com. Application deadline: 26th of August 2022.

If you have any questions to the position, you can call Mr. Lars Liengård Holten Møller, Head of Cell Bank & DS Manufacturing, Cell: +45 4015 9749 or Ms. Louise Puge Clemmensen, Team Lead for CB and DS Manufacturing, Cell: +45 4049 8416.

We are looking forward to your application!