ZipRecruiter

Log In

1

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

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 ...

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 ...

Emvia, Inc.

Automation Validation Lead

Andover, MA · On-site +1

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 ...

Genezen

Sr. System Administrator

Lexington, MA · On-site

$140K - $165K/yr

Install and upgrade computer components and software, manage virtual servers, and integrate automation processes per Computer System Validation SOPs and protocols * Ensure that the IT environment is ...

Genezen

Sr. System Administrator

Lexington, MA · On-site

$96K - $130K/yr

Install and upgrade computer components and software, manage virtual servers, and integrate automation processes per Computer System Validation SOPs and protocols * Ensure that the IT environment is ...

next page

Showing results 1-20

All JobsComputer System Validation JobsComputer System Validation Jobs in Malden, MA

Computer System Validation information

See Malden, MA salary details

$11

$56

$89

How much do computer system validation jobs pay per hour?

As of Jul 17, 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 job?

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 the Computer System Validation position, 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.

What is the work of computer system validation?

Computer System 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 is essential in industries like pharmaceuticals and healthcare to ensure data integrity and regulatory compliance.

What degree is best for cis jobs?

For Computer System Validation (CSV) roles, a bachelor's degree in computer science, information technology, life sciences, or engineering is typically preferred. Relevant certifications such as GxP or validation-specific training can enhance job prospects, and strong knowledge of regulatory requirements like FDA or EMA guidelines is beneficial.

What is the salary of SoC validation engineer?

The salary of a SoC validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Professionals in this role often have skills in hardware description languages and verification tools, which can influence compensation.
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 job categories do people searching Computer System Validation jobs in Malden, MA look for? The top searched job categories for Computer System Validation jobs in Malden, MA 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 July 2026, with employment types broken down into 1% As Needed, 78% Full Time, 18% Part Time, 1% Temporary, and 2% Contract. Highlights an 82% Physical, 1% Hybrid, and 17% Remote job distribution, with an average salary of $117,836 per year, or $56.7 per hour.
Sr. CSV Validation Engineer

Sr. CSV Validation Engineer

Genezen

Lexington, MA • On-site

$115K - $140K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 25 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 incumbent is responsible for leading computerized systems validation projects. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GMP software applications. Key deliverables are preparation of relevant documentation to meet regulatory requirements for new and existing products (Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices). Collaborate with cross functional teams, ensure compliance with regulatory requirements, and drive best‑in‑class validation practices that support our Quality Management System and operational excellence.

ESSENTIAL JOB FUNCTIONS

  • Lead Protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GMP software applications
  • Review and approve qualification documentation on behalf of the validation function
  • Evaluate, audit, and guide software validation activities to ensure compliance with FDA, ISO, Data Integrity guidance, and internal standards
  • Support investigations into protocol nonconformances and site deviations
  • Serve as initiator and owner of validation related change controls and corrective and preventative actions
  • Author standard operating procedures related to CSV validation practices
  • Support the execution and generation of formal risk assessments
  • Enhance CSV validation programs
  • Analyze validation data, identify gaps, and support investigations and corrective actions
  • Represent CSV during audits and regulatory inspections

SPECIAL WORK REQUIREMENTS

  • Fully onsite position
  • Strong communication skills
  • Familiarity with Microsoft Office, Excel, and Visio
  • Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
  • Ability to manage multiple activities
  • The ability to communicate with fellow project team members
  • Criminal background check required
  • Other duties as assigned

EDUCATION/CERTIFCATIONS/LICENSES

A minimum of a Bachelor's degree in Engineering, Computer
Science or related discipline

Desired

ON-THE-JOB EXPERIENCE

7+ years of 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 experience levels from Genezen and other contract firms

Essential

The ability to report on project activity in a clear and concise manner

Essential

The ability to communicate with fellow project team members

Essential

Understanding of cGMP regulations

Essential

Technical writing ability

Essential

Familiarity with Microsoft Office

Essential

Ability to work well with diverse groups in a matrix-style, growing, safety focused organization

Essential

Ability to manage multiple activities with challenging timelines

Essential

In depth knowledge of 21 CFR Part 11, EU GMP Annex 11 and GAMP5 computerized system

Essential

Pay Range:
The annual salary range for this position based upon level hired is: $115,000 - $140,000

Work Environment

  • Regularly sit for extended 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.