Validation Expert Thermal Mapping
Vor 6 Tagen
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**:
**Validation Expert Thermal Mapping (f/m/d) 100%**:
As a successful Validation Expert you ensure that Thermal Mappings are performed according to global and local company policies and standards as well as legal requirements and requirements set by regulatory authorities. You are responsible for planning, developing and executing thermal mappings for fridges, freezers, incubators, autoclaves, freeze dryers and fermentation vessels for our three locations in Denmark and Switzerland.
**My main tasks will be**:
- Leads assigned thermal mappings during the build of our facility in Visp
- Leads assigned validations for annual recurring routine tasks in our facilities in Basel & Hørsholm, DK
- Coordinates and communicates with stakeholders to ensure equipment availability and timely completion
- Creation of protocols and reports for validations in accordance with policy and procedures
- Performs periodical assessment of validity of equipment qualification & validation / periodic reviews
- Reviews and analyzes related deviations, CAPAs and changes
**I bring with me**:
- Experienced chemical / pharmaceutical technical assistant or bachelor degree in Pharmaceutical Technology, Chemistry, Biotechnology or equivalent
- A minimum of 3 years of experience in Qualification / Validation
- Good understanding of manufacturing processes and related process equipment
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment
- Structured, focused and well-organized working attitude
- Self-dependent way of working and taking ownership of assigned tasks
- Proficient in German and English
- Willingness to travel to our different sites (Denmark, Visp, Basel)
- Driver’s license
**My reasons for choosing Bacthera**:
- Innovative and fast-growing start-up company with short decision-making processes
- Flexible working hours (possibility of Home Office)
- Motivated, agile and multinational team
- Very good pension fund and attractive salary
- Fringe benefits (e.g. Lunch card, deduction at different stores, Job ticket for public transport)
- 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.**
**Sandra Gamboni**
Global Head of HR
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