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Computer System Validation Jobs in Shrewsbury, MA

Staffingine LLC

Data Warehouse BI Tester

Boston, MA · On-site

Extensive experience with pharma companies, including strong CSV (Computer System Validation) skills * Capable of executing both GxP and non-GxP programs/projects * Excellent communication skills ...

Syner-G

Validation Engineer

Boston, MA · On-site +1

Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. * Hands-on equipment start-up and troubleshooting experience is highly desired. * Report writing experience ...

Syner-G

Validation Engineer

Boston, MA · On-site

Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. * Hands-on equipment start-up and troubleshooting experience is highly desired. * Report writing experience ...

Syner-G

Validation Engineer

Boston, MA · On-site

Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. * Hands-on equipment start-up and troubleshooting experience is highly desired. * Report writing experience ...

Syner-G

Validation Engineer

Waltham, MA · On-site +1

Perform P&ID walkdowns to verify installation and system readiness. * Conduct thermal mapping of ... While performing the duties of this job, the employee is regularly required to use a computer ...

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All JobsComputer System Validation JobsComputer System Validation Jobs in Shrewsbury, MA

Computer System Validation information

See Shrewsbury, MA salary details

$10

$55

$87

How much do computer system validation jobs pay per hour?

As of Aug 5, 2026, the average hourly pay for computer system validation in Shrewsbury, MA is $55.34, according to ZipRecruiter salary data. Most workers in this role earn between $42.60 and $65.62 per hour, depending on experience, location, and employer.

What are some typical challenges faced in computer system validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.

What is a computer system validation?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What are the key skills and qualifications needed to thrive in computer system validation, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring software and systems meet compliance standards such as GxP. It involves documentation, testing, and validation of computer systems, often requiring knowledge of regulatory requirements and validation tools. The field offers stable employment opportunities and career growth for professionals with technical skills and certifications like GAMP or 21 CFR Part 11 compliance.
What job categories do people searching Computer System Validation jobs in Shrewsbury, MA look for? The top searched job categories for Computer System Validation jobs in Shrewsbury, MA are:
What cities near Shrewsbury, MA are hiring for Computer System Validation jobs? Cities near Shrewsbury, MA with the most Computer System Validation job openings:
Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Shrewsbury, MA as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $115,108 per year, or $55.3 per hour.

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

SmartIPlace

Needham, MA • On-site

$113K - $156K/yr

Contractor

Re-posted 8 hours 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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