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Brooksource · 3 weeks ago

CSV Engineer

United States

Full-time

Remote

Entry, Mid Level

2+ years exp

Brooksource is seeking a CSV Engineer to support Computer System Validation (CSV) activities for GxP-regulated systems. The role involves executing validation deliverables and ensuring compliance with FDA regulations while collaborating with cross-functional teams to maintain the validated state of systems.

EmploymentHuman ResourcesInformation Technology

Growth Opportunities

H1B Sponsor Likely

Responsibilities

Assist in the development and execution of validation documentation, including:

User Requirements Specifications (URS)

Functional Specifications (FS)

Validation Plans (VP)

Test Scripts (IQ/OQ/PQ)

Traceability Matrices

Perform system assessments to determine GxP applicability and validation requirements

Ensure adherence to Part 11 controls electronic records and signatures

Collaborate with cross-functional teams to resolve validation issues

Maintain accurate and complete validation documentation in the designated repository

Qualification

FDA Quality System regulationsComputer System ValidationSDLC development methodologyProject Management processesData integrity principlesAgile methodologyWaterfall methodologyDocument management conceptsRequirements engineeringTest environments

Required

2-5 years' experience with FDA Quality System regulations, standards and processes in process model for software development including:

Knowledge of procedure or instruction development and document management concepts

Knowledge of Quality methods e.g. documentation management, training, review or inspection, statistical sampling, internal/external audit, troubleshooting, investigation or analysis tools/techniques

Knowledge of SDLC development methodology e.g. V-model, GAMP, Agile

Knowledge of Architecture Standards and concepts, configuration diagrams, infrastructure topology

Knowledge of Project Management processes and Work Break Down Structures

Knowledge of requirements engineering, test environments and protocols

Knowledge of Computer System Validation concepts

Knowledgeable in project management, work breakdown structure

Some supervision is required, can create and author deliverables, can provide some training

Provides input to Manager to determine work priorities

Works with supervision in application of skills across multiple Business Segments

Preferred

Experience with electronic systems such as LIMS, ERP, or Quality Management Systems

Knowledge of data integrity principles

Familiarity with Agile or Waterfall methodologies

Company

Brooksource

Glassdoor4.0

Brooksource is a single source for project and supplemental support through contract employment, contract-to-hire labor employment.

Founded in 2000

Indianapolis, Indiana, USA

1001-5000 employees

http://www.brooksource.com

H1B Sponsorship

Brooksource has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2020 (10)