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Computer System Validation Manager Jobs in Somerset, MA

Pharmaron

QC Informatics Specialist

Coventry, RI

$80K - $120K/yr

Computer System Validation/QC Informatics Specialist Salary Range: $80,000 - $120,000/yr. Location ... With the support of the reporting manager in the Quality Control & Analytical department, lead ...

Posted today

Pharmaron

QC Informatics Specialist

Coventry, RI · On-site

$80K - $120K/yr

Computer System Validation/QC Informatics Specialist Salary Range: $80,000 - $120,000/yr. Location ... With the support of the reporting manager in the Quality Control & Analytical department, lead ...

New

Noblis

Computer Systems Analyst

Newport, RI · On-site

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

Cadence Inc

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.

Amgen, Inc.

Validation Engineer

West Greenwich, RI · On-site

In this vital role is within the Product Lifecycle Management organization at Amgen Rhode Island ... Plan and coordinate and execute equipment and system qualification activities across a range of ...

Amgen SA

Validation Engineer

West Greenwich, RI · On-site

$90 - $130/hr

In this vital role is within the Product Lifecycle Management organization at Amgen Rhode Island ... Plan and coordinate and execute equipment and system qualification activities across a range of ...

New

Amgen Inc. (IR)

Validation Engineer

West Greenwich, RI · On-site

$86 - $116/hr

In this vital role is within the Product Lifecycle Management organization at Amgen Rhode Island ... Plan and coordinate and execute equipment and system qualification activities across a range of ...

Amgen

Validation Engineer

West Greenwich, RI · On-site

In this vital role is within the Product Lifecycle Management organization at Amgen Rhode Island ... Plan and coordinate and execute equipment and system qualification activities across a range of ...

Calise Bakery

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 ...

Calise Bakery

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 ...

Millstone

Senior Validation Engineer

Fall River, MA · On-site

... manage communications with customers. * Ability to negotiate with clients on project timelines, processes, and validation activities. * Experience in developing systems to improve standard processes ...

Steve Madden

Store Assistant Manager

Wrentham, MA · On-site

$18 - $24.50/hr

Process information or merchandise through the computer system and POS register system. Assist Store Manager in the selection and hiring of qualified candidates. Be flexible and occasionally perform ...

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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 26, 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 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 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 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:

Computer System Validation Manager jobs near you

Computer Validation Engineer IV

Fall River, MA • On-site

Celldex Therapeutics
Biotechnology Research and Development • 201 - 500 employees
Learn more about Celldex Therapeuticsexternal

$101K - $131K/yr

Other

Medical, Retirement, PTO

Posted 5 days ago

Job description

Overview
The incumbent will oversee and coordinate new projects related to validation deliverables and qualifications to ensure existing and new system installations meet all internal and external compliance requirements such as 21 CFR Part 11, EU GMP, and GLP requirements throughout the systems development life cycle. This position works on moderately complex problems of diverse scope where analysis of data requires solid evaluation of identifiable factors.
Responsibilities
  • Work closely with GMP, GLP and IT business units to provide Computer System Validation Services to implement validated system and maintain the validated state of current systems
  • Acts as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Quality Risk Management for GMP/GLP systems.
  • Applies and enhances existing computer system validation programs for the validation of new production and manufacturing /laboratory computer systems, including major capital projects and computer systems for both early phase and commercial phase.
  • Ensure existing systems and new systems are compliant with all applicable regulations based on their applicable use at Celldex
  • Coordinate Incident Management, along with the related corrective and preventative actions required to establish/maintain validated systems
  • Develop Standard Operating Procedures and policies to support computer validation systems for GMP/GLP
  • Develop training materials and provide training to Celldex staff related to the computer validation systems for GMP/GLP
  • Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and IT
  • Manages multiple simultaneous validation, revalidation, and change control activities
  • Develop validation project management deliverables as needed such as plans, qualification protocols, gap assessments, risk/impact assessments, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change control / change management and continuous improvement for GMP/GLP
  • Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes for GMP/GLP systems
  • Support and provide input into system administration and maintenance procedures to ensure adequate controls for maintaining the validated state for GMP/GLP systems

Qualifications
  • 8+ years applicable work experience in cGMP/GLP related industry
  • Bachelor's degree in a technical discipline (computer or biological sciences), or equivalent
  • Demonstrated experience coordinating validation projects in validated and regulated environments
  • Demonstrated experience reviewing / evaluating legacy systems, and provide gap reports/assessments per each system per 21 CFR Par 11 compliance
  • Experience with network qualification required
  • Experience with ERP system qualification required
  • Experience with Veeva products required
  • Successful implementation of ERP, Veeva, lab, production systems required.
  • Proven track record in validation and qualification of complex computer systems
  • Demonstrable knowledge of GxP environs such as cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, 15 and GAMP standards
  • Experience with qualification of AI preferred
  • Experience with qualification of lab software systems required
  • Excellent writing and communications skills
  • Excellent people and interpersonal skills
  • High level of collaboration and working on and leading teams

Compensation Statement
The expected base salary for this position is: $101005.00 to $131175.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.

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