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Computer System Validation Csv Jobs in Massachusetts

Moderna, Inc.

Senior Engineer I, Automation

Marlborough, MA · On-site

$107K - $141K/yr

Knowledge of GAMP, Computer System Validation (CSV), and regulatory compliance requirements * Background in CSV and regulatory compliance (21 CFR Part 11, Annex 11) * Experience developing automation ...

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Computer System Validation Csv information

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

As of Aug 10, 2026, the average hourly pay for computer system validation csv in Massachusetts is $56.57, according to ZipRecruiter salary data. Most workers in this role earn between $42.55 and $70.34 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in computer system validation CSV?

To thrive as a Computer System Validation (CSV) professional, you need a solid understanding of computer science, regulatory compliance (such as FDA 21 CFR Part 11), and validation methodology, often supported by a degree in a scientific or technical field. Familiarity with documentation tools, validation protocols, and quality management systems, as well as certifications like PMP or Six Sigma, is highly beneficial. Strong attention to detail, problem-solving abilities, and effective communication skills enable effective cross-functional collaboration. Mastering these skills ensures accurate validation processes, regulatory compliance, and smooth project execution in highly regulated environments.

What is a computer system validation CSV?

A Computer System Validation (CSV) job involves ensuring that computerized systems used in regulated industries, such as pharmaceuticals and medical devices, comply with industry standards and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). CSV professionals develop validation protocols, conduct testing, and document system performance to ensure data integrity, reliability, and compliance. Their role is critical in maintaining system quality and avoiding regulatory risks.

What are some typical challenges faced by computer system validation CSV professionals and how are they addressed?

Computer System Validation (CSV) professionals often encounter challenges such as keeping up with evolving regulations, managing complex documentation requirements, and ensuring robust communication between IT, quality assurance, and business teams. Navigating system upgrades while maintaining compliance with strict regulatory standards requires careful planning and thorough risk assessment. Successful candidates address these challenges by staying current with industry guidance, utilizing validation templates and checklists, and fostering strong teamwork across various departments. Building collaborative relationships and maintaining meticulous records help ensure both audit readiness and smooth project completion.

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Computer System Validation Csv jobs near you
Infographic showing various Computer System Validation Csv job openings in Massachusetts as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 11% Part Time, and 2% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $117,673 per year, or $56.6 per hour.

GxP Validation Engineer/Analyst (Lab Equipment)

WHITE COLLAR TECHNOLOGIES INC

Cambridge, MA • On-site

Contractor

Medical, Dental, Vision

Re-posted 18 days ago

Job description

Responsibilities:

· Provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for the implementation of analytical assays on new instrumentation. This scope includes QC Instruments (both portable and computer-controlled).

· Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final reports for systems with short-term/completed remediation

· Performing supporting remediation work in the form of SOP revisions

· Executing change controls and validation test plans/protocols when required per remediation plans

· Responsible for the development and execution of general deliverables, such as Risk Assessments, Validation Plans, Change Impact Assessments, Design Specifications, User Requirements, Functional Requirements, Configuration Specification, Requirement Trace Matrices, IQ/OQ/UAT/PQ Protocols, and Summary Reports.

Desired Skills and Experience:

· Author, maintain, revise, and/or approve of the Validation Plan.

· Lead the resolution of deviations noted during protocol execution.

· Manage and approve vendor’s documentation as appropriate.

· Ability to impact and influence people/areas in matters related to Validation and GxP compliance.

· Ability to work in a fast-moving dynamic small company environment.

· Ability to mentor junior team members.

· Experiences in other validation areas which may include CSV qualification and Facility Equipment and Utility is a plus.

Required Qualifications:

· Validation experience in a biotech/pharmaceutical environment, specializing in Instrument or Computer System Validation

· Bachelor's Degree in Engineering, Life Science or Computer Science is required.

· Excellent working knowledge of process automation and computer system validation concepts, GAMP methodologies, CFR Part 11 Electronic Records and Signatures requirements and latest industry expectations for data integrity.

Company Description

White Collar Technologies is a boutique human capital consultancy firm specializing in information technology and engineering consulting for life science sector. Our consultants serve multitude of clients within Pharmaceutical, Biotech, Medical Device, Clinical Research and Healthcare verticals.
We offer our workers Medical Dental and Vision healthcare benefits.