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Senior Computer System Validation Csv Jobs (NOW HIRING)

Soltech PR

WI · On-site

$60 - $80/hr

The Computer System Validation (CSV) Specialist/Engineer will support the validation and lifecycle management of computerized systems within a regulated pharmaceutical/biotechnology manufacturing ...

ClifyX

Computer system Validation Tester

Somerset, NJ · On-site

... CSV • Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures. • Provide training related ...

Soltech PR

$60 - $80/hr

The Computer System Validation (CSV) Specialist/Engineer will support the validation and lifecycle management of computerized systems within a regulated pharmaceutical/biotechnology manufacturing ...

Prophecy Technologies

R&D CSV Engineer

Wilmington, DE · On-site

This role is for a Computer System Validation (CSV) Engineer with strong R&D domain knowledge, focusing on ensuring GxP compliance for various systems. The engineer will be responsible for applying ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

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Senior Computer System Validation Csv information

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How much do senior computer system validation csv jobs pay per hour?

As of Sep 10, 2026, the average hourly pay for senior computer system validation csv in the United States is $64.77, according to ZipRecruiter salary data. Most workers in this role earn between $51.68 and $73.56 per hour, depending on experience, location, and employer.

What is a senior computer system validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.

What are the key skills and qualifications needed to thrive as a senior computer system validation (CSV) professional?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges senior computer system validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

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Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in the United States as of September 2026, with employment types broken down into 100% Full Time. Highlights an 50% In-person, and 50% Remote job distribution, with an average salary of $134,726 per year, or $64.8 per hour.

Urgent On-Site Opening for Senior CSV Engineer - Needham, MA - Need Local to MA Only.

Needham, MA • On-site

SmartIPlace
IT Services • 51 - 200 employees
Learn more about SmartIPlaceexternal

$113K - $156K/yr

Contractor

Re-posted 5 days ago

Job description

Note :

  • Need Local to MA, with same State I’d Only.

Position Overview :

  • Need someone with Lab experience.
  • We are looking for 4 Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Candel’s QC Laboratory reactivation project.
  • This role will focus on EMS, BMS, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, SciNotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements.
  • The CSV Engineer will develop and execute validation deliverables, manage ERES assessments, and provide GMP-ready reports within the accelerated project schedule.

Tasks, Responsibilities, and Deliverables:

  • Draft and execute URS for computerized lab systems and informatics platforms.
  • Perform and document risk assessments and ERES (Electronic Records and Electronic Signatures) assessments.
  • Develop and execute validation deliverables: FS/DS, IQ, OQ, PQ protocols, and traceability matrices.
  • Validate EMS/BMS systems for environmental monitoring and building controls.
  • Validate laboratory software platforms, including HPLC/qPCR data systems, SciNotes, and Blue Mountain.
  • Verify compliance with data integrity principles (ALCOA+), Part 11, and Annex 11 requirements.
  • Document results, deviations, and resolution activities.
  • Deliver complete GMP-ready CSV reports for QA review and approval.
  • Collaborate with CQV Engineers, Technical Writers, and QA to ensure consistency across FEU, LEQ, and CSV validation workstreams.

Required Skills, Scope, and Experience:

  • Bachelor’s degree in Computer Science, Engineering, or related technical field.
  • 8–10 years’ experience in computer system validation within GMP-regulated pharmaceutical/biotech environments.
  • Strong knowledge of 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5.
  • Proven experience validating EMS, BMS, and laboratory informatics/data systems.
  • Proficiency in authoring and executing FS/DS, IQ, OQ, PQ, and trace matrices.
  • Experience performing ERES assessments and applying risk-based validation approaches.
  • Familiarity with eQMS or informatics platforms (e.g., SciNotes, Blue Mountain, Empower, LabWare).
  • Strong technical writing and documentation skills.
  • Ability to manage parallel CSV activities in a compressed timeframe with accuracy and compliance.
     
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About Smart-iPlace

Sourced by ZipRecruiter

SMART-iPLACE provides innovative staffing and consulting solutions that help our clients achieve their business objectives. We can understand and support all areas of your IT systems from back-end infrastructure to front-end personal productivity. Our goal is create innovative IT solutions that enable your business to be more agile and competitive.

Industry

It services

Company size

51 - 200 Employees

Headquarters location

Irving, TX, US

Year founded

2021

Social media

Facebook

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