Biotech Laboratory Automation Specialist
Vor 4 Tagen
We are seeking a highly skilled Laboratory Systems and Automation Expert to support our client, a leading Biotech company in the Berne area. As a key member of their team, you will be responsible for ensuring the smooth operation of laboratory instrumentation and automation infrastructure.
Responsibilities:- Support laboratory instrumentation & automation infrastructure in an operational testing environment
- Ensure instrumentation and equipment are qualified, calibrated, maintained according to company policies and procedures and according to GxP requirements
- Create documentation in English and German for qualification, validation and lifecycle management of existing and new laboratory automation systems, analytical instruments, software applications in collaboration with Engineering and I&T departments
- Manage local and global qualification and validation projects
- Collaborate with internal/external stakeholders within qualification and validation projects for technical requirement specifications, data integrity and automation activities
- Support update of procedures related to laboratory instrumentation and computerized systems (i.e. USP, 21CFR Part 11, Annex 11 regulations) to ensure compliance with guidelines and industry best practice, as well as harmonization within the global organization
To succeed in this role, you should have a strong background in a relevant scientific discipline, such as Biology, Microbiology, Chemistry, Bioinformatics or Computer Science. Additionally, you should have at least 5 years' experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation.
Other essential qualifications include first project management experience in an operational environment, knowledge of regulations on computerized systems and laboratory automation, and the ability to work independently and as part of a team in a high-performance environment.
As a valuable asset to our client's team, you will be expected to communicate effectively in both English and German, both orally and in writing, and possess strong analytical/problem-solving skills, as well as a technical IT affinity and organizational skills.
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