CSV Engineer

Roles & Responsibilities :

• We are now looking for a resource on the validation side of things going on here. Depending on the resource, we're looking for someone with (LabVantage) LIMS and quality systems validation experience, and / or general more broad Pharma / Biotech CSV experience that could back-fill as staff augmentation.
• Engagement would be (at least) through the end of the year.
• Potential in-scope activities.
• i. CSV / Lab Systems Qualification document / deliverable authoring.
• ii. Test script / protocol authoring (potential execution).
• iii. SOP modification / authoring.
• iv. Spreadsheet Validation.
• For the right person : local / hybrid / on-site, remote, and offshore would all be considered.
• i. Veeva (Quality, eTMF, RIM).
• ii. Val Genesis.
• iii. Lab Vantage.
• iv. Various (Stand-Alone) Lab Computing systems.