Job Openings IT Lab Validation Analyst (remote potential in PST)

About the job IT Lab Validation Analyst (remote potential in PST)

Safebox is looking for an experienced IT Lab Validation Analyst to move a clients laboratory from R&D to GMP lab testing.

Safebox is a boutique consulting organization focused on helping clients design and implement large-scale technology initiatives that deliver measurable outcomes and drive business value.

Primary Responsibilities:

The IT Lab Validation Analyst will partner with each computer-controlled instrument business owner, the Quality Validation Lead and the Lab IT Analyst to create/edit the following SDLC deliverables:

  • Change Control Record

  • New Supplier Request to Qualify Vendors

  • User and IT Administration SOPs​

  • Validation Determination​

  • Validation Plan​

  • User Requirements Specification​

  • 21 CFR Part 11 and Annex 11 Assessment​

  • Risk Assessment​

  • Configuration Spec​ification

  • IOPQ Validation​ Protocol and Test Cases

  • IOPQ Validation Summary Report​

  • Requirements Trace Matrix​

  • Validation Plan Summary Report​

Knowledge and Experience with:

  • Valgenesis

  • Nugenesis

  • Veeva Quality Docs

  • ServiceNow

  • Druva Backup Tool

  • Acronis Imaging Tool

  • Blue Mountain RAM

  • Knowledge/experience with the following instrument software types:

    • Cellaca

    • Glomax

    • DDPCR

    • Nanodrop

    • NC-200

    • Microbeta

    • Cytoflex

    • Faxitron

  • Data Integrity

  • 21CFRPart 11

  • GDP, GMP, GLP, GCP

  • Validation of computer controlled instruments

The following computer-controlled instrument workstations are to be validated:

  • Cellaca (1) -Full from ground up (create all deliverables from scratch)​

  • Glomax (1) - Full from ground up (create all deliverables from scratch)​

  • DDPCR (4) - Full from ground up (create all deliverables from scratch)​

  • Nanodrop (1) - Full from ground up (create all deliverables from scratch)​

  • NC-200 (2) - Update existing documentation, rerun test cases​

  • Microbeta (1) - Update existing documentation, rerun test cases​

  • Cytoflex (2) - Update existing documentation, rerun test cases​

  • Faxitron (1) - Update existing documentation, rerun test cases​

Location: Onsite in Thousand Oaks, CA

Pay: up to $85.50/hr

Please note:

  • This is a 6 month contract role ending 3/25/24 with possibility for extension up to 12 months

  • Direct application only we do not accept staffing applications; no Corp to Corp

  • Must be eligible to work in the US; we do not sponsor Visas

  • Failure to answer all application questions may result in automatic rejection


Or refer someone