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Computer Systems Validation Jobs in Massachusetts

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

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 ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

$115K - $140K/yr

... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV experiences including as a Validation lead Essential The ability to communicate with employees of all ...

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Computer Systems Validation information

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$11

$59

$93

How much do computer systems validation jobs pay per hour?

As of Aug 18, 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 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 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 are some common challenges faced in a computer systems validation 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 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 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 August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 7% Part Time, 3% Contract, and 1% Nights. Highlights an 88% Physical, 3% Hybrid, and 9% Remote job distribution, with an average salary of $123,391 per year, or $59.3 per hour.

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Alkermes

Waltham, MA • On-site

$110K - $126K/yr

Full-time

Posted 8 days ago

Job description


This position provides leadership and accountability for Digital Quality across the organization's Quality, Regulatory, and R&D systems landscape, with responsibility for supporting computer system validation activities in alignment with applicable regulatory expectations, internal procedures, and data integrity requirements. The role is focused on ensuring GxP computerized systems are implemented, maintained, and governed in a compliant, risk-based, and inspection-ready manner throughout the system lifecycle.
Responsibilities
  • Provide support for computer system validation activities across Quality, Regulatory, and R&D systems, including ensuring projects comply with applicable regulations, internal policies, and SOPs
  • Represent CSV in project teams and collaborate with stakeholders, as applicable. Measure and report project execution progress
  • Determine levels of importance or risk to be assigned to elements under review - to ensure validation efforts are directed at the systems that have the potential to impact product quality, efficacy, and data integrity using a variety of tools including GAMP 5 and Quality Risk Management
  • Support the development, review, approval, and execution of validation-related documentation throughout the system lifecycle
  • Conduct and approve risk assessments in line with the company Quality Risk Management policy
  • Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed computerized system
  • Understand the science and areas of technical knowledge that underpin area of focus and must be able to apply this knowledge in the development of validation approach and in the presentation, documentation, and review of outcome
  • Exposure to Validation of AI and AI validation methodology
  • Contribute effectively to GxP compliance maintenance through monitoring, review, assessment, and qualification activities, including Change Control, Deviations, CAPAs, Periodic Reviews, Access Reviews, and SOP updates, along with attendance in forums where such KPIs are reviewed
  • Support compliance of computerized systems with current corporate global computerized validation policies and Digital Quality expectations
  • Support the creation and maintenance of computer system validation templates in ValGenesis and general job aids that are relevant and available to applicable users
  • Support regulatory inspections and internal audits by providing CSV-related responses and support, as applicable, to inspectors and auditors
  • Serve as a CSV-related supplier or third-party vendor audit activities, including management of corrective actions to closure as needed
  • Provide relevant training to key project personnel before computerized system validation activities begin, as applicable to the Digital Quality lead role
  • Lead and/or assist training content development and delivery related to validation methodology
  • (As required) Move to other areas of activity applying skills in logic and scientific method while quickly assimilating knowledge and contributing to delivery
  • Represent in cross-functional forums and follow up on any resulting action items in a timely manner
  • Understand best industry practice, current developments, and opportunities arising for the organization
  • Actively participate in Professional/Industry groups to learn, to influence, and to represent the organization

Qualifications
  • Bachelor's degree in computer science, Life Sciences, Engineering, or related field, with 9+ years of progressive experience in Digital Quality within a GxP-regulated pharmaceutical or biotech environment (master's degree with 7+ years also considered)
  • Highly Quality minded with experience supporting computer system validation activities in a GxP-regulated environment is preferred. Strong quality systems, compliance, and data integrity experience is required, including experience with Enterprise Quality Systems (e.g., LMS, Veeva DMS, TrackWise/TrackWise Digital) and paperless validation platforms such as ValGenesis
  • Knowledge of GxP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11, Part 312, Part 314, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9, and Q10
  • Excellent interpersonal, leadership, collaborative, communication (written and verbal), and time-management skills are essential
  • Proven track record in current and previous roles. Results and Performance driven
  • Strong leadership skills and ability to work within cross-functional teams. Experience leading teams is essential
  • Flexibility and adaptability to changing needs and requirements

The annual base salary for this position ranges from $110,000 to $126,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
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About Us
Why join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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