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