CSA Validation Lead

Title : CSA Validation Lead

Location : San Francisco, CA - Onsite

Duration : 6 months

Rate : $72/hr on C2C & $62/hr on W2

Position : C2C Position

Relevant Experience (in Yrs.): 10+

Detailed Job Description:

· We are looking for an experienced CSV/CSA Validation Lead with strong pharmaceutical/biotech experience to lead validation activities for laboratory instrument integrations and cloud-based data platforms.

Key Responsibilities:

· Lead CSV/CSA validation activities following GAMP 5 and FDA regulations.

· Prepare and review URS, VMP, Risk Assessments, IQ/OQ/PQ, RTM, and VSR documents.

· Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles.

· Validate laboratory instrument interfaces such as HPLC, UPLC, Flow Cytometry, and dd PCR.

· Support LIMS, ELN, and laboratory data integration.

· Manage validation lifecycle, change control, and audit readiness.

· Collaborate with QA, IT, engineering, and laboratory teams.

Must Have Skills:

· CSV/CSA Validation

· Validation Documentation

· FDA & GxP Compliance

· Tetra Data Platform

· Laboratory Instrument Integration