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Computer System Validation Manager Jobs in Massachusetts

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

... years of Computer System Validation experience • In depth CSV experiences including as a ... to manage multiple activities with challenging timelines • In depth knowledge of 21 CFR Part 11 ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA

$115K - $140K/yr

... Quality Management System and operational excellence. ESSENTIAL JOB FUNCTIONS * Lead Protocol ... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV ...

AMRESCO

Quality Validation Engineer

Devens, MA · Hybrid

Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Project management skills: planning, scheduling, stakeholder management, risk communication, and ...

Avantor, Inc.

Quality Validation Engineer

Devens, MA · On-site

Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Project management skills: planning, scheduling, stakeholder management, risk communication, and ...

Avantor Inc.

Quality Validation Engineer

Devens, MA · Hybrid

Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Project management skills: planning, scheduling, stakeholder management, risk communication, and ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA

$115K - $140K/yr

... Quality Management System and operational excellence. ESSENTIAL JOB FUNCTIONS * Lead Protocol ... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

$115K - $140K/yr

... Quality Management System and operational excellence. ESSENTIAL JOB FUNCTIONS * Lead Protocol ... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV ...

Sebela Pharma

CQV/Validation Engineer

Holbrook, MA · On-site

$33 - $43/hr

Support equipment, utility, facility, process, cleaning, and computerized system validation ... Auto CAD experience preferred. * Flexible to work overtime (paid) as needed. Pay Range: $33.00 ...

Cipla

Validation Supervisor

Fall River, MA · On-site

$76K - $103K/yr

Project Lead - Validation (Supervisor) FLSA Classification : Full-Time, Exempt/Salary Professional ... management tools (e.g., MS Project, Primavera). Experience with SAP systems for engineering and ...

Cipla

Validation Supervisor

Fall River, MA · On-site

$76K - $103K/yr

... management tools (e.g., MS Project, Primavera). • Experience with SAP systems for engineering and financial operations. • PMP certification is a plus. • Experience with audit preparation ...

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All JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Massachusetts

Computer System Validation Manager information

See Massachusetts salary details

$51.9K

$115.1K

$175.3K

How much do computer system validation manager jobs pay per year?

As of Jun 25, 2026, the average yearly pay for computer system validation manager in Massachusetts is $115,126.00, according to ZipRecruiter salary data. Most workers in this role earn between $81,400.00 and $144,200.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a Computer System Validation Manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a Computer System Validation Manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are the most commonly searched types of Computer System Validation jobs in Massachusetts? The most popular types of Computer System Validation jobs in Massachusetts are:
What are popular job titles related to Computer System Validation Manager jobs in Massachusetts? For Computer System Validation Manager jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Massachusetts look for? The top searched job categories for Computer System Validation Manager jobs in Massachusetts are:
What cities in Massachusetts are hiring for Computer System Validation Manager jobs? Cities in Massachusetts with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Massachusetts as of June 2026, with employment types broken down into 94% Full Time, 3% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $115,126 per year, or $55.3 per hour.
Sr. CSV Validation Engineer

Sr. CSV Validation Engineer

Genezen

Lexington, MA • On-site

Full-time

Posted 13 days ago

Job description

Job Summary:
Genezen is a company focused on gene therapy, providing process development and producing GMP viral vectors for clinical trials. The Sr. CSV Validation Engineer will lead computerized systems validation projects, ensuring compliance with regulatory requirements and driving best-in-class validation practices.
Responsibilities:
• 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
Qualifications:
Required:
• A minimum of a Bachelor’s degree in Engineering, Computer Science or related discipline
• 7+ years of Computer System Validation experience
• In depth CSV experiences including as a Validation lead
• The ability to communicate with employees of all experience levels from Genezen and other contract firms
• The ability to report on project activity in a clear and concise manner
• The ability to communicate with fellow project team members
• Understanding of cGMP regulations
• Technical writing ability
• Familiarity with Microsoft Office
• Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
• Ability to manage multiple activities with challenging timelines
• In depth knowledge of 21 CFR Part 11, EU GMP Annex 11 and GAMP5 computerized system
• Strong communication skills
• Familiarity with Microsoft Office, Excel, and Visio
• Criminal background check required
Company:
Genezen offers contract process development, GMP viral vector production, transduced cell manufacturing, and testing services. Founded in 2014, the company is headquartered in Indianapolis, USA, with a team of 201-500 employees. The company is currently Growth Stage.

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