Contracting – Brabant Wallon
ELN Business Analyst & Developer
Functieomschrijving
- Business Analysis: conduct stakeholder interviews, process mapping, and current state assessments across CMC Dev laboratories to translate & align needs into clear requirements or user stories, and testing scripts / criteria.
- ELN template Design & Development: Apply established processes & style guide to design and configure ELN experiment templates, forms, calculation sheets, workflows, approval steps, audit trails, etc.
- ELN structured data structuration: Configure data mapping according to CMC data models ensuring data/metadata schemas are aligned to FAIR principles and scientific and industry domain standards
- Optimize usability and search/discovery/re-usability (naming conventions, taxonomies, tagging, template reuse, Inventory), & integration with other computerized systems
- Implement or coordinate & monitor development, testing, issues/defects identification, prioritization & fixes
- Ensure fit for purpose of Digital Operations solutions, and solution & business readiness for implementation – further support change management by monitoring the adoption and performance of newly implemented solutions
- Deliver process and solutions documentation, datasets and trainings
- Contribute to solutions lifecycle with change requests, impact assessment and continuous improvement
Profiel
- Hands-on expertise configuring and developing within IDBS E-WorkBook (on premise or Cloud) or similar ELN solution
- Hand-on experience and strong understanding of CMC Development laboratory workflows (small molecules, biologics, analytical development, sample & inventory management)
- Business Analysis & Product Skills with demonstrated proactiveness, curiosity, analytical and self-reliant mindset
- Knowledge of regulatory requirements and quality standards in the biopharmaceutical industry is a plus
- Excellent communication, interpersonal and facilitation skills
- Continuous improvement and customer-centric thinking, but balanced with an ability to challenge legacy landscape
Aanbod
- Bedrijfswagen
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, Toon emailadres