Description

In this role you will collaborate with relevant stakeholders to ensure laboratory equipment and automation systems are operating in a qualified environment. With your proactive and self-responsible approach you take decisions and drive progress forward.

Tasks and responsibilities

• Support laboratory instrumentation and automation infrastructure in an operational testing environment
• Ensure laboratory instrumentation and equipment are qualified, calibrated and maintained according to company policies and procedures and in compliance with GxP requirements
• Create documentation in English and German for qualification, validation and lifecycle management of existing and newly implemented laboratory automation systems, analytical instruments, and software applications in collaboration with Engineering and I&T departments
• Manage local and global qualification and validation projects
• Collaborate with internal and 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

Your profile

• University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, Bioinformatics, Computer Science etc.)
• 5+ years' experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, experience in equipment qualification or CSV and lifecycle activities
• First project management experience in an operational environment
• Knowledge of regulations on computerized systems and laboratory automation and willingness to extend skills and know-how on the field
• Strong written & verbal communication in German and English, both oral and written to ensure effective collaboration with cross-functional teams both locally and globally across all sites
• Strong analytical/problem solving, technical IT affinity and organizational skills
• Able to work independently and as a team member in a high performance environment

General information

• Start date: asap
• Duration of employment: planned for 1 year
• Place of work: Bern
• Workload: 100 %