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Computer System Validation Manager Jobs in Massachusetts

Zifo

Validation Analyst

Norwood, MA

Experience authoring and reviewing computer system validation lifecycle documents. * Experience with Document Management, QMS, ServiceNow and System Administration activities. * Experience authoring ...

Zifo

Validation Analyst

Norwood, MA · On-site

Experience authoring and reviewing computer system validation lifecycle documents. * Experience with Document Management, QMS, ServiceNow and System Administration activities. * Experience authoring ...

Zifo

Validation Analyst

Norwood, MA · On-site

Experience authoring and reviewing computer system validation lifecycle documents. * Experience with Document Management, QMS, ServiceNow and System Administration activities. * Experience authoring ...

Trelleborg

Software Validation Engineer

Northborough, MA · On-site

$95K - $105K/yr

... Quality Management System and applicable regulations. Tasks and Responsibilities * Conduct ... Participate in system implementations, enhancements, and integrations as the computer system ...

Genezen

Validation Engineer II/III (CSV)

Lexington, MA

$90K - $130K/yr

This includes writing all validation deliverables within the Computer System Lifecycle, e.g ... Assess the impact of system changes thru change management and change control systems; participate ...

Genezen

Validation Engineer II/III (CSV)

Lexington, MA

$90K - $130K/yr

This includes writing all validation deliverables within the Computer System Lifecycle, e.g ... Assess the impact of system changes thru change management and change control systems; participate ...

Genezen

Validation Engineer II/III (CSV)

Lexington, MA · On-site

$90K - $130K/yr

This includes writing all validation deliverables within the Computer System Lifecycle, e.g ... Assess the impact of system changes thru change management and change control systems; participate ...

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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 May 31, 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
Global Computer Validation Specialist

Global Computer Validation Specialist

Global Channel Management, Inc.

Marlborough, MA

$40/hr

Contractor

Posted 23 days ago

Job description

Company Description

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation.  Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function.  Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. 


Job Description

Hands on position responsible for authoring test scripts and other
CSV documents required for the validation of GAMP 5 Category 4
(configurable off the shelf) computer systems.  Candidates should be
familiar with COTS systems used for clinical development and quality
activities in a pharmaceutical environment.  Work with business users
and Information Technology to ensure the systems remain in a validated
state through appropriate change control procedures. May require
participation in early morning and/or evening teleconferences with
global project teams.

  1. Create
    and/or review computer system validation test scripts, validation
    schedules, risk assessments, requirement specifications, protocols and
    reports, traceability matrices, and validation summary reports according
    to the timelines in the project plan.  Review applicable procedures and
    system training manuals as applicable. Participate in project team
    meeting. (85%)
  2. Document
    requirements for business requirements, system security, user roles,
    workflows, data flows, GxP requirements and how these systems fit into
    the larger IT infrastructure. (10%)
  3. Work
    with IT and User Groups to: (a) evaluate change control requests, (b)
    assess regulatory risk associated with such requests and (c) determine
    the corresponding validation requirements for such changes. (5%)
Qualifications
  • 2 - 3 years experience writing CSV test scripts, protocols and summary reports in global environments
  • Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline. 

Knowledge and skills (general and technical):

  • Sufficiently
    knowledgeable of FDA/EU/MHLW Regulatory Requirements and industry best
    practices for computerized system validation to complete tasks
  • Experience working with global teams particularly with team members from Japan
  • Understands lifecycle approach as well as risk based approach to validation
  • Generally familiar with GXP regulations particularly in the GCP and Quality areas
  • Able to work both independently and as a member of a cross-functional project team
  • Good written and oral communication skills
  • Good problem solving skills
  • Microsoft products such as Word, Excel, Project, and Visio.
  • Familiar
    with Information Technology principles, functionalities and
    capabilities of computer systems; and how computer systems relate to and
    integrate with larger corporate IT infrastructures
Additional Information

$40/hr

6 MONTHS +

Global Channel Management logo

About Global Channel Management

Sourced by ZipRecruiter

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Global Channel Management understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at the same time requiring the best talent for the job. GCM's Ownership and Management teams have extensive Staffing, Recruiting, HR and Executive Leadership knowledge, Experience and Expertise. Our Understanding and Commitment to our Client's Satisfaction are key reasons GCM has been successful in establishing long term relationships.

Industry

Recruiting and staffing services

Company size

11 - 50 Employees

Headquarters location

Austell, GA, US

Year founded

2009

Social media

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