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Computer Systems Validation Jobs in Massachusetts

Eversource Energy

Computer Technician

Westwood, MA · On-site

$55.54 - $57.91/hr

This function is responsible for installing devices such as PC's, operating systems, and software ... valid Massachusetts driver's license. LOCAL 369 POSTING #: 3142 DEPARTMENT:Service Desk/End User ...

4G Clinical

Senior Quality Auditor

Wellesley, MA · On-site +1

$89K - $105K/yr

A minimum of 6-8 years' experience as an client audit host in a regulatory environment. * 3-5 years' experience of auditing experience of Computer Systems Validation and RTSM experience is desired.

Syner-G

Validation Engineer

Waltham, MA · On-site

The Validation Engineer will act as a technical subject matter expert across facility systems, lead ... While performing the duties of this job, the employee is regularly required to use a computer ...

Genezen

Stability Manager, Quality Control

Lexington, MA

$130K - $150K/yr

... computer systems validation. The Manager, QC Stability provides leadership and strategic oversight of the stability programs from early phase through commercialized programs. This role ensures ...

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All JobsComputer Systems Validation JobsComputer Systems Validation Jobs in Massachusetts

Computer Systems Validation information

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$11

$59

$93

How much do computer systems validation jobs pay per hour?

As of Jun 13, 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 is the work of computer system validation?

Computer Systems Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV helps maintain data integrity, quality, and regulatory compliance in industries like pharmaceuticals and healthcare.

What is the salary of computer system validation?

The salary for a Computer Systems Validation specialist typically ranges from $70,000 to $120,000 annually, depending on experience, location, and certifications such as GxP or 21 CFR Part 11. Entry-level roles may start lower, while experienced professionals with regulatory knowledge can earn higher salaries in the pharmaceutical, biotech, or medical device industries.

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.

Is computer system validation a good field?

Computer Systems Validation (CSV) is a vital role in regulated industries such as pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It involves skills in validation protocols, documentation, and understanding regulatory requirements like FDA or EMA guidelines, making it a stable and in-demand career path for those with technical and regulatory knowledge.

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.

Is CSV a skill?

In the context of Computer Systems Validation, CSV is not a skill but an abbreviation for Computer System Validation, which involves verifying that computer systems meet regulatory requirements. Skills relevant to CSV include knowledge of validation protocols, regulatory standards like GxP, and proficiency with validation tools and documentation. Understanding these concepts is essential for professionals working in regulated industries such as pharmaceuticals and biotech.

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 are popular job titles related to Computer Systems Validation jobs in Massachusetts? For Computer Systems Validation jobs in Massachusetts, the most frequently searched job titles are:
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:
Computer Systems Validation jobs near you
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.
CQV/Validation Engineer

CQV/Validation Engineer

Sebela Pharmaceuticals Inc.

Holbrook, MA

$33 - $43/hr

Full-time

Posted 8 days ago

Job description

Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in Women’s Health. Our Vision is to build the leading Gastroenterology company in the U.S., with a complementary focus on innovation in Women’s Health, premised on our expertise in pharmaceutical development and commercialization. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has its contract development and manufacturing organization (CDMO) in Holbrook, MA, offering pharmaceutical-development and in-house manufacturing services for specialty gastroenterology products.
We value dedication, energy, and enthusiasm, and we focus on innovation and results while striving to achieve our corporate mission and vision. Sebela Pharmaceuticals is committed to cultivating an inclusive environment where all employees are treated with respect. We accomplish this by fostering a culture of diversity, equity and inclusion, which is essential to innovation and continuous improvement. Sebela operates from three locations in Roswell, Georgia, Braintree and Holbrook, MA and headquarters in Dublin, Ireland.
The CQV/Validation Engineer is responsible for supporting the activities required to implement the Holbrook site’s validation plan in compliance with current industry and regulatory expectations. This role supports the development, review, execution, and completion of qualification, validation, and related cGMP documentation.
PRINCIPAL DUTIES AND RESPONSIBILITIES
  • Participate in validation, qualification, and commissioning activities for pharmaceutical manufacturing equipment, utilities, facilities, processes, cleaning programs, and computerized systems.
  • Participate in validation and CQV projects from planning through documentation, execution, discrepancy resolution, approval, and closeout.
  • Develop, review, and/or execute validation documentation such as change control, test scripts, protocols, reports, User Requirements Specifications, risk assessments, traceability matrices, and related supporting documents.
  • Support equipment, utility, facility, process, cleaning, and computerized system validation activities, as assigned.
  • Document and assist in resolving protocol discrepancies, deviations, incidents, nonconformances, and validation issues, including impact assessments and corrective actions/CAPA.
  • Collaborate with Manufacturing, Engineering, Quality Assurance, Quality Control, Technical Operations, IT, and external vendors to support validation deliverables and project timelines.
  • Review and revise GMP documentation, including SOPs, batch records, protocols, reports, forms, and related controlled documents.
  • Complete GMP documentation and validation records accurately, clearly, and contemporaneously in accordance with company procedures and good documentation practices.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have knowledge and experience in Equipment and Utility Qualification, Process Validation, Cleaning Validation and/or Computerized System Validation. The requirements listed below are representative of the knowledge, skills and/or abilities required. Equivalent combination of education and relevant experience will be considered.
  • Bachelor’s degree or higher in Engineering, Life Sciences or related discipline.
  • 3+ years relevant FDA regulated industry/validation experience or an equivalent amount of validation experience.
  • Experience with validation, qualification, commissioning, CQV, manufacturing support, quality systems, engineering documentation, or technical project execution.
  • Familiarity with one or more of the following areas is preferred: equipment qualification, facility qualification, utility qualification, cleaning validation, process validation, computerized system validation, or commissioning.
  • Ability to write, review, or execute technical documents such as protocols, test scripts, reports, SOPs, batch records, specifications, risk assessments, or deviation investigations.
  • Strong problem-solving, communication, and technical writing skills.
  • Knowledge of good documentation practices and cGMPs required.
  • Knowledge of 21 CFR Part 11, validation lifecycle principles, or risk-based validation approaches preferred.
  • Auto CAD experience preferred.
  • Flexible to work overtime (paid) as needed.
Pay Range: $33.00 - $43.00 per hour/annualized at $68-89K not including any overtime pay (this reflects our reasonable and good faith estimate of what will be paid at the time of posting). Competitive benefits package included.

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