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Computer Systems Validation Jobs in Massachusetts

Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...

Automation Validation Lead Location : Andover, MA Duration - 6 months (possible extension ... Ethernet Profibus OPC The ideal candidate should be familiar with the following computer system ...

$80K - $98K/yr

Lead validation deviation investigations * Assist during the design, evaluation, and risk assessment of new computer systems, equipment, facilities, utilities, processes, and cleaning * Assist during ...

Validation Engineer II

Milford, MA · On-site

$80K - $98K/yr

Lead validation deviation investigations * Assist during the design, evaluation, and risk assessment of new computer systems, equipment, facilities, utilities, processes, and cleaning * Assist during ...

Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Experience: 3-7+ years of validation experience in a regulated manufacturing environment with ...

Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Experience: 3-7+ years of validation experience in a regulated manufacturing environment with ...

Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Experience: 3-7+ years of validation experience in a regulated manufacturing environment with ...

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Computer Systems Validation information

See Massachusetts salary details

$11

$59

$93

How much do computer systems validation jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for computer systems validation in Massachusetts is $59.32, according to ZipRecruiter salary data. Most workers in this role earn between $45.67 and $70.34 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Computer Systems Validation, and why are they important?

To thrive in Computer Systems Validation, you need a solid understanding of regulatory requirements (such as FDA or EMA guidelines), software development life cycles, and risk management, often supported by a degree in life sciences, IT, or engineering. Experience with validation frameworks, documentation tools, and systems like GAMP 5 and knowledge of 21 CFR Part 11 compliance are typically required. Attention to detail, strong analytical thinking, and effective communication set professionals apart in this role. These skills and qualifications ensure validated systems are compliant, reliable, and support organizational quality and regulatory objectives.

What is the difference between Computer Systems Validation vs Quality Assurance Specialist?

AspectComputer Systems ValidationQuality Assurance Specialist
CertificationsGAMP, CSV-specific trainingISO 9001, Six Sigma
Work EnvironmentRegulated industries like pharma, biotechManufacturing, software, service sectors
Primary FocusEnsuring computer systems meet regulatory standardsEnsuring overall product/service quality
Common UsageValidation of software, hardware in complianceProcess audits, quality improvement

Computer Systems Validation and Quality Assurance Specialist roles overlap in ensuring compliance and quality. However, CSV focuses specifically on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. Quality Assurance Specialists have a broader scope, overseeing overall quality processes across various sectors. Both roles require similar certifications and work environments but differ in their primary objectives and specific tasks.

What is computer systems validation?

Computer systems validation (CSV) is the process of ensuring that computer-based systems used in regulated industries, like pharmaceuticals and biotechnology, perform their intended functions consistently and reliably. This process involves documenting and testing systems to confirm they meet regulatory requirements, such as those set by the FDA. The goal is to ensure data integrity, product quality, and patient safety by minimizing the risk of system errors or failures. CSV typically includes activities like risk assessment, test planning, execution, and maintaining thorough records for audits.

What are some common challenges faced in a Computer Systems Validation (CSV) role, and how can they be addressed?

Professionals in Computer Systems Validation often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and coordinating with cross-functional teams. Staying updated through regular training and industry resources helps address compliance changes. Clear communication and collaboration with IT, Quality Assurance, and business stakeholders are essential for efficient validation processes. Utilizing validation lifecycle management tools and standardized templates can also streamline documentation and reduce errors.
What job categories do people searching Computer Systems Validation jobs in Massachusetts look for? The top searched job categories for Computer Systems Validation jobs in Massachusetts are:
Infographic showing various Computer Systems Validation job openings in Massachusetts as of June 2026, with employment types broken down into 1% As Needed, 73% Full Time, 16% Part Time, 2% Temporary, and 8% Contract. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $123,391 per year, or $59.3 per hour.
GxP Validation Engineer/Analyst (Lab Equipment)

GxP Validation Engineer/Analyst (Lab Equipment)

WHITE COLLAR TECHNOLOGIES INC

Cambridge, MA • On-site

Contractor

Medical, Dental, Vision

Posted 16 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.