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Computer System Validation Jobs in Malden, MA (NOW HIRING)

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 ...

IT EXCEL LLC

Jr QA Tester

Cambridge, MA

$55K - $58K/yr

We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...

IT EXCEL LLC

Jr QA Tester

Cambridge, MA · On-site

$55K - $58K/yr

We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...

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 ...

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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Computer System Validation information

See Malden, MA salary details

$11

$56

$89

How much do computer system validation jobs pay per hour?

As of Aug 6, 2026, the average hourly pay for computer system validation in Malden, MA is $56.65, according to ZipRecruiter salary data. Most workers in this role earn between $43.61 and $67.21 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 are popular job titles related to Computer System Validation jobs in Malden, MA? For Computer System Validation jobs in Malden, MA, the most frequently searched job titles are:
What cities near Malden, MA are hiring for Computer System Validation jobs? Cities near Malden, MA with the most Computer System Validation job openings:
Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Malden, MA as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 13% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $117,836 per year, or $56.7 per hour.

Lead, QCTS Data Integrity & Computerized Systems

Genezen

Lexington, MA

$110K - $150K/yr

Full-time

Re-posted 20 days ago

Job description

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The Lead, Quality Control Technical Services (QCTS) – Data Integrity is responsible for ensuring that QC laboratory systems, instruments, software, and associated data workflows meet regulatory expectations for data integrity and GxP compliance. This role provides expert oversight and support across QC laboratory for computerized system implementation, instrument qualification, assay data workflows, software validation, and data governance activities. The lead partners closely with QC operations, Validation, IT, and system owners to ensure that QC systems are designed and maintained, and monitored in alignment with 21 CFR Part 11 and EU Annex 11, ALCOA+ principles, and corporate data integrity standards. The role supports audits and inspections, authors technical documentation, resolves data-related issues, and contributes leadership through scientific and systems expertise.

ESSENTIAL JOB FUNCTIONS

  • Serve as the QCTS Data Integrity and Computerized System Validation SME, ensuring QC laboratory systems comply with 21 CFR part 11, EU Annex 11 and internal DI policies.
  • Provide expertise and support for QC computerized systems, including instrument software, standalone analytical instruments, and data acquisition/processing tools, including Excel spreadsheets.
  • Partner with QC labs leads, system owners, Validation, and IT to ensure robust lifecycle management of QC systems, including system qualification, validation, periodic review, and configuration controls.
  • Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment.
  • Lead implementation of change management of QC instruments, software upgrades, and new laboratory technologies to ensure readiness for GMP use.
  • Maintain and improve data integrity practices within the QC function, including data review workflows, audit trails, user access, data storage, and backup/restore procedures.
  • Support QC investigations (deviations, OOS/OOT, CAPAs) involving data integrity, system performance, or data workflow failures; provide technical root-cause contributions.
  • Lead authoring and maintenance of QCTS procedures, work instructions, validation protocol, validation summary reports, and guidance documents relating to computerized systems, instrument qualification (IOQ, PQ), and data integrity.
  • Coordinate with external qualified service providers to ensure QC systems are validated.
  • Support internal and external audits/inspections as the QCTS Data Integrity SME, providing evidence for QC systems, validation documentation, and data governance controls.
  • Deliver training, guidance, and technical mentorship to QC analysts and system users to strengthen data integrity awareness and consistent system usage across QC.

SPECIAL JOB REQUIREMENTS

  • Adaptability required as work schedule may change based on business needs
  • Criminal background check required
  • Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Degree in science-related field

ON-THE-JOB EXPERIENCE

10+ years of experience in IT Systems/CSV, Enterprise Solutions (Veeva, CDS), QMS (electronic and paper), and data integrity, Excel spreadsheet validation

SKILLS / ABILITIES

Prior experience working in a CDMO environment

10+ years working in a Good Manufacturing Practices (GMP) environment

Subject matter expert in 21 CFR Part 11, GAMP 5, EU Annex 11

Subject matter expert in Good Documentation Practices (GDP)

Excellent computer literacy (MS Word, Excel, SmartSheets)

Excellent project management tools (MS project, SmartSheets)

Excellent executive communication skills, both written and oral

Pay Range:
The annual salary range for this position is $110,000-$150,000.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

  • Regularly sit for long periods of time

Movement

  • Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
  • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

  • Frequently lift and/or move up to 10 pounds
  • Rarely lift and/or move up to 25 pounds

Vision

  • Frequently utilize close vision and the ability to adjust focus

Communication

  • Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

  • Paid vacation days, amount based on tenure
  • Paid sick time
  • 10 observed holidays + 2 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary
  • Share Appreciation Rights
  • Choice of several healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Employer-paid basic term life/personal accident insurance
  • Voluntary disability, universal life/personal accident insurance
  • Accidental Death & Dismemberment (AD&D) Insurance

ADDITIONAL DETAILS

  • Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
  • This position requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • Genezen participates in EVerify.
  • Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.