Manufacturing Technologies & Engineering
QLS are recruiting for a Manufacturing Technologies & Engineering to join a project with a global Biopharmaceutical Company based in Lucerne on a contract basis for 2 years with option of an extension.
The company employs a diverse group of highly skilled scientists, engineers, technicians and process specialists from more than 15 nations and provides an important contribution to the company’s endeavor to bring new innovative medicines to patients as fast as possible, while applying highest quality standards to all activities. As a company, they are committed to ‘Inventing for Life’ in all that we do. They keep the patient at the very heart of all that they do and strive to find solutions and treatments for some of the world’s mostchallenging healthcare needs.
- Support introduction of novel, innovative solutions supporting the manufacture of biologics within the facility.
- Capital Requests and Sourcing
- Qualification of Devices / Equipment• Authoring of batch records, sampling plans, and standard operating procedures.
- Act as SME for implemented new technologies, guiding the implementation into routine production.
- Author Protocols and Prepare Design of Experiments to show comparability of new technologies versus legacy
Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.
Ability to solve problemsand take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
For novel and resupply of Continuous Manufacturing Clinical Supply Drug Substance.
- Support the day-to-day operations of batch and continuous manufacturing processes.
- Operate equipment according to batch records, sampling plans and standard operating procedures.
- Work with Facility Management / internal team members in the in the maintaining of GMP status of responsible equipment devices in routine monitoring, calibration, maintenance, and certifications.
A degree qualification in a relevant field (Science/Technical). An Advanced Degree (BSc or MSc) qualification is desirable.• A minimum of 3 years’ experience working in a relevant academic or industry field.
Technical knowledge with Biologics drug substance upstream operations, downstream operations, analytical testing or process development.
Verbal or spokencommunication skills in German (B1) and/or English (B2).
- Knowledge of design and operation of automated systems such as Delta V.
- Ability to think logically and be proactive under pressure.
- Ability to work as part of a team and on own initiative in a constructive manner.
- cGMP experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment
- Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification
Please could you send any correspondence in English. Please quote reference 53268 in all correspondence.