LES / ELN Specialist @ Billennium Remote

LES / ELN Specialist @ Billennium

Remote

Pharmaceutical Industry Experience:

• Domain knowledge in fields of biotechnology / chemistry / biochemistry / microbiology / analytical chemistry and related

Quality Control/R&D Laboratory experience:

• Good knowledge of Ph. Eur, USP etc.
• Familiarity with ICH, MHRA etc.
• Experience in working in a regulated laboratory environment (ISO or GMP)
• Experience in various laboratory techniques: Chromatography, Spectrometry, Coulometry, Particle analysis etc.
• Experience in working with LIMS systems (LabWare, CoreLims, LabVantage)
• Experience in working with ELN/LES systems (especially ONELab from Biovia)
• Experience in working with:Empower, LabX, Chromeleon, Mass Hunter, OpenLab as a user and system administrator, troubleshooting resolving software issues
• Knowledge of CSV, GAMP5, 21 CFR p. 11, EU Annex 11
• Experience in pharmaceutical method validation and development, cleaning validation, instrument qualification
• Good understanding of laboratory processes (certification, IPC, sample cycle etc)
• Experience in creating documentation (GDP)

IT Related Skills/IT Related Experience:

• Knowledge of Agile methodologies as Scrum framework (Scrum, SAFe)
• Knowledge regarding Business Analysis (areas & techniques) BPMN fundamentals
• Ability to work with end users to design complex workflows
• Understanding of Data Integrity related topics
• Preparing high quality documentation (CSV 5)
• English B2 or higher
• Exceptional communication skills (meeting facilitation, active listening, formal communication etiquette, transparent expression)
• Competence to identify and address complex problems
• Pro-activeness in searching for customer needs/problems
• Ability to work in a team
• Experience in working in an international environment

Nice to have:

• Knowledge of SQL language (Oracle)
• Experience in HP -ALM (designing test cases, executing tests, defect management)
• Experience in ServiceNow
• Experience in JavaScript
• Understanding of code versioning concept

,[Creating automated laboratory workflows, Interacting with business for feedback and new recipe ideas, Reporting deffects and testing new software features, Designing new core system functionalities e.g.: reporting, interfaces.] Requirements: LIMS, ELN/LES , ISO, GAMP, Scrum, Chromatography, Spectrometry Additionally: Sport subscription, Private healthcare, International projects.

Kategorie

other

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