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Computer System Validation Manager Jobs in Somerset, MA

... system software, computer equipment, and the regulations, structure, techniques, and management practices. * Recognizing probable conflicts and integrating diverse data elements and sources, and ...

Technical Project Manager About the Role We are seeking an experienced Technical Project Manager to ... Understanding of GxP, Computer System Validation (CSV/CSA), and data integrity requirements.

Ability to manage multiple projects and priorities in a fast-paced environment * On-site work ... Familiarity with Computer System Validation (CSV) and digital manufacturing systems Location * This ...

Validation Engineer II

Cranston, RI · On-site

$83K - $105K/yr

Conduct risk assessments and manage change controls. * Ensure regulatory compliance. (GMP, GLP, CSV ... Monitor system performance and lead requalification activities. * Qualify suppliers and vendors.

Computer Engineer

Newport, RI · On-site

$115K - $124K/yr

Configure, integrate, and validate software and hardware components within complex system ... Support system build activities, software updates, and configuration management throughout the ...

IT Manager

Lincoln, RI · On-site

$86K - $106K/yr

Test, maintain, and monitor computer programs and systems, including coordinating the installation ... Consult with management to ensure agreement on system principles. * Expand or modify system to ...

IT Manager

Lincoln, RI · On-site

$86K - $106K/yr

Test, maintain, and monitor computer programs and systems, including coordinating the installation ... Consult with management to ensure agreement on system principles. * Expand or modify system to ...

... standards, validation practices, privacy, and security requirementsrelevant to R&D systems ... Bachelor's degreerequired(Information Technology, Engineering, Computer Science, or related field)

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Computer System Validation Manager information

See Somerset, MA salary details

$48.2K

$107K

$162.9K

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

As of Aug 5, 2026, the average yearly pay for computer system validation manager in Somerset, MA is $106,987.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,600.00 and $134,000.00 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 Somerset, MA? The most popular types of Computer System Validation jobs in Somerset, MA are:
What job categories do people searching Computer System Validation Manager jobs in Somerset, MA look for? The top searched job categories for Computer System Validation Manager jobs in Somerset, MA are:
What cities near Somerset, MA are hiring for Computer System Validation Manager jobs? Cities near Somerset, MA with the most Computer System Validation Manager job openings:

Validation Engineer II

Thermo Fisher Scientific

Plainville, MA • On-site

$66K - $99K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 11 days ago


Thermo Fisher Scientific rating

7.7

Company rating: 7.7 out of 10

Based on 422 frontline employees who took The Breakroom Quiz

197th of 536 rated manufacturers


Job description

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our collaborative team as a Validation Engineer II at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. In this role, you'll be responsible for ensuring compliance, quality, and operational excellence across our facilities through comprehensive validation activities. Working with advanced technologies and diverse teams, you'll help maintain high standards in pharmaceutical manufacturing, laboratory operations, and quality control.
REQUIREMENTS:
• Advanced degree with no prior experience required, Bachelor's degree plus 2 years of experience preferably within validation in a GMP/regulated environment, or High School Diploma with 4+ years of experience.
• Preferred Fields of Study: Engineering, Life Sciences, Chemistry, or related technical field
• Valid driver's license with ability to travel up to 25% as needed
• Comprehensive knowledge of cGMP, FDA regulations, and industry standards (ISO, GAMP5)
• Strong technical writing skills for validation documentation
• Experience with IQ/OQ/PQ protocols and execution
• Proficiency in risk assessment and gap analysis
• Experience managing validation projects independently
• Strong data analysis and problem-solving capabilities
• Clear verbal and written communication skills
• Proficient in Microsoft Office applications
• Knowledge of calibration and metrology principles
• Experience with automation systems and computer system validation
• Ability to work in cleanroom environments when required
• Effective interpersonal skills for team collaboration
• Ability to manage multiple projects
• Experience with quality management systems and documentation
• Knowledge of statistical analysis and process control methods
• Consistent record of completing projects on schedule in a deadline-oriented environment
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Other
Relocation assistance is not provided.
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Compensation and Benefits
The salary range estimated for this position based in Massachusetts is $66,000.00-$99,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  • Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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