A minimum of a Bachelor’s degree in an Engineering or Scientific field.
6-10 years of role relevant experience.
Demonstrated experience with Polarion or excellent ALM software experience.
Strong Lab Informatics experience, particularly with LIMS (LabVantage).
Excellent communication skills for client interactions.
Ability to work independently on tasks.
Experience authoring, editing, and executing validation documents.
Knowledge of FDA regulations, ISPE guidelines, and ISO standards.
Responsibilities:
Our team needs a senior level CSV Engineer with ALM experience, ideally with Polarion.
Handle projects from a technical and validation perspective, including calculation validations in LabVantage, instrument integration, JMP/Statistica integration, data migration from legacy systems, LIMS integration, and other related tasks.