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Computer System Validation Manager Jobs in Massachusetts

Genezen

Validation Technician (Temp)

Lexington, MA

$27 - $38/hr

JOB SUMMARY The Validation Technician will be responsible for assisting the Validation manager in ... Familiarity with GE Kaye Validator and/or lives data acquisition systems. * Generates validation ...

Sanofi

Data System Analyst

Waltham, MA · On-site

Author SOPs and training materials related to data management and digital workflows. * Support Computer System Validation (CSV) activities in partnership with Validation teams. * Collaborate with ...

Sanofi

Data System Analyst

Framingham, MA · On-site

Author SOPs and training materials related to data management and digital workflows. * Support Computer System Validation (CSV) activities in partnership with Validation teams. * Collaborate with ...

Sanofi

Data System Analyst

Framingham, MA

Author SOPs and training materials related to data management and digital workflows. * Support Computer System Validation (CSV) activities in partnership with Validation teams. * Collaborate with ...

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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 Jun 1, 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
Urgent On-Site Opening for Senior CSV Engineer - Needham, MA - Need Local to MA Only.

Urgent On-Site Opening for Senior CSV Engineer - Needham, MA - Need Local to MA Only.

SmartIPlace

Needham, MA • On-site

$113.80K - $156.30K/yr

Contractor

Posted 24 days ago

Job description

Note :

  • Need Local to MA, with same State I’d Only.

Position Overview :

  • Need someone with Lab experience.
  • We are looking for 4 Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Candel’s QC Laboratory reactivation project.
  • This role will focus on EMS, BMS, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, SciNotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements.
  • The CSV Engineer will develop and execute validation deliverables, manage ERES assessments, and provide GMP-ready reports within the accelerated project schedule.

Tasks, Responsibilities, and Deliverables:

  • Draft and execute URS for computerized lab systems and informatics platforms.
  • Perform and document risk assessments and ERES (Electronic Records and Electronic Signatures) assessments.
  • Develop and execute validation deliverables: FS/DS, IQ, OQ, PQ protocols, and traceability matrices.
  • Validate EMS/BMS systems for environmental monitoring and building controls.
  • Validate laboratory software platforms, including HPLC/qPCR data systems, SciNotes, and Blue Mountain.
  • Verify compliance with data integrity principles (ALCOA+), Part 11, and Annex 11 requirements.
  • Document results, deviations, and resolution activities.
  • Deliver complete GMP-ready CSV reports for QA review and approval.
  • Collaborate with CQV Engineers, Technical Writers, and QA to ensure consistency across FEU, LEQ, and CSV validation workstreams.

Required Skills, Scope, and Experience:

  • Bachelor’s degree in Computer Science, Engineering, or related technical field.
  • 8–10 years’ experience in computer system validation within GMP-regulated pharmaceutical/biotech environments.
  • Strong knowledge of 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5.
  • Proven experience validating EMS, BMS, and laboratory informatics/data systems.
  • Proficiency in authoring and executing FS/DS, IQ, OQ, PQ, and trace matrices.
  • Experience performing ERES assessments and applying risk-based validation approaches.
  • Familiarity with eQMS or informatics platforms (e.g., SciNotes, Blue Mountain, Empower, LabWare).
  • Strong technical writing and documentation skills.
  • Ability to manage parallel CSV activities in a compressed timeframe with accuracy and compliance.
     
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About Smart-iPlace

Sourced by ZipRecruiter

SMART-iPLACE provides innovative staffing and consulting solutions that help our clients achieve their business objectives. We can understand and support all areas of your IT systems from back-end infrastructure to front-end personal productivity. Our goal is create innovative IT solutions that enable your business to be more agile and competitive.

Industry

It services

Company size

51 - 200 Employees

Headquarters location

Irving, TX, US

Year founded

2021

Social media

Facebook

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