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Computer System Validation Jobs in Malden, MA (NOW HIRING)

Moderna, Inc.

Sr. Engineer, GxP Systems

Norwood, MA · On-site

$121K - $194K/yr

Conduct Computer System Validation (CSV) activities by developing and executing SDLC qualification protocols and writing system configuration specifications, risk assessments, and administration ...

Moderna Therapeutics

Sr. Engineer, GxP Systems

Norwood, MA · On-site

$121K - $194K/yr

Conduct Computer System Validation (CSV) activities by developing and executing SDLC qualification protocols and writing system configuration specifications, risk assessments, and administration ...

Emvia, Inc.

Automation Validation Lead

Andover, MA · On-site +1

Automation Validation Lead Location : Andover, MA Duration - 6 months (possible extension ... Ethernet Profibus OPC The ideal candidate should be familiar with the following computer system ...

Staffingine LLC

Data Warehouse BI Tester

Boston, MA · On-site

Extensive experience with pharma companies, including strong CSV (Computer System Validation) skills * Capable of executing both GxP and non-GxP programs/projects * Excellent communication skills ...

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Computer System Validation information

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$56

$89

How much do computer system validation jobs pay per hour?

As of Jun 11, 2026, the average hourly pay for computer system validation in Malden, MA is $56.65, according to ZipRecruiter salary data. Most workers in this role earn between $43.61 and $67.21 per hour, depending on experience, location, and employer.

What are some typical challenges faced in Computer System Validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.

What is a Computer System Validation job?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What is the salary of computer system validation?

The salary for a Computer System Validation specialist typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Certifications such as GAMP or CSV training can influence earning potential, and roles often require knowledge of regulatory standards like FDA or ISO.

What are the key skills and qualifications needed to thrive in the Computer System Validation position, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

What is the work of computer system validation?

Computer System Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV is essential in industries like pharmaceuticals and healthcare to ensure data integrity and compliance with regulations such as FDA or GMP.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It often requires knowledge of regulatory guidelines, validation protocols, and tools like GxP and 21 CFR Part 11. The field offers steady demand, opportunities for certification, and roles in quality assurance and compliance management.

Is CSV a skill?

In the context of Computer System Validation, CSV refers to Computer System Validation itself, which is a process rather than a skill. However, skills related to CSV include understanding validation protocols, regulatory requirements, and proficiency with validation tools and documentation. These skills are essential for professionals performing CSV tasks in regulated industries like pharmaceuticals and biotech.
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Computer System Validation jobs near you

Validation Engineer III

Barry-Wehmiller Companies

Boston, MA • On-site

Full-time

Posted 26 days ago

Job description

About Us:
BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.
Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.
Job Description:
Job Description:
Job Summary
The Validation Engineer III will serve as a key member of the validation team, providing expert-level support to ensure facility equipment, utilities, processes, instrumentation, and computerized systems are qualified and maintained in a validated state in compliance with applicable regulatory requirements. This role functions as a Validation Subject Matter Expert (SME) responsible for leading validation activities, authoring protocols and reports, and providing technical guidance to cross-functional teams. The Validation Engineer III will coordinate and execute qualification activities while collaborating with internal stakeholders and external vendors to support ongoing operations and capital projects.
Key Responsibilities
Validation Documentation & Execution
  • Author, review, and approve validation protocols, reports, and associated documentation including acceptance criteria development
  • Establish, revise, and maintain validation master plans, procedures, and lifecycle documentation for qualification of equipment, systems, and processes in accordance with cGMP requirements
  • Execute and oversee IQ/OQ/PQ protocols for equipment, utilities, and systems
  • Review and complete documentation in accordance with cGMP, ALCOA+ principles, and data integrity requirements
Project & Program Management
  • Lead and manage validation-related project activities including scheduling, resource coordination, protocol execution, and report review
  • Manage external vendors and contractors performing qualification activities
  • Serve as a key member of project teams for design, procurement, installation, and commissioning of new equipment and facility expansion projects
  • Develop and maintain validation project timelines and deliverables
Compliance & Change Control
  • Review proposed changes to validated systems and provide impact assessments
  • Identify validation requirements necessary to maintain systems in a validated state following change implementation
  • Manage periodic requalification activities to ensure equipment, utilities, and processes remain compliant
  • Support equipment and building monitoring systems compliance and updates
Technical Expertise
  • Serve as Subject Matter Expert (SME) in one or more of the following disciplines:
    • Process Mapping
    • Quality Management (Quality Risk Assessments; Change Controls; Deviations; CAPA; Documentation)
    • Equipment qualification (autoclaves, controlled temperature units, filling equipment)
    • Cleaning validation Aseptic process simulation (media fills)
    • Computer system validation (CSV)
    • Process validation Utility qualification (WFI, purified water, clean steam, HVAC)
    • Environmental monitoring systems
  • Provide technical guidance and troubleshooting support for equipment and system failures
  • Deliver training on validation program elements to junior validation personnel
Quality Systems Support
  • Author and support equipment and process-related deviation investigations and CAPA activities
  • Perform and support risk assessments (FMEA, etc.) and data integrity assessments
  • Support internal audits and regulatory agency inspections
  • Ensure all work is performed in accordance with SOPs, cGMPs, quality standards, and safety procedures
Qualifications
Education
  • Bachelor's degree in Engineering, Life Sciences, or related scientific discipline required
  • Master's degree (MS/MSc) preferred
Experience
  • Minimum 5+ years of professional experience in validation, engineering, or operations within a regulated environment
  • Minimum 4+ years of direct experience in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environment
  • Demonstrated expertise as a Subject Matter Expert (SME) in one or more validation disciplines
  • Experience with GMP utilities (WFI, purified water, clean steam, compressed gases, HVAC) and manufacturing equipment
  • Experience supporting regulatory inspections (FDA, EMA, or equivalent) preferred
  • Capital project experience including equipment design, selection, and commissioning preferred
Skills & Competencies
  • Strong technical writing skills with ability to author clear, compliant documentation
  • Solid working knowledge of cGMP regulations, FDA guidance documents, and industry standards (ISPE, PDA, GAMP)
  • Understanding of GDP requirements and ALCOA+ data integrity principles
  • Excellent communication and interpersonal skills with ability to interface across all organizational levels
  • Strong project management and organizational skills
  • Ability to work independently with minimal supervision while also functioning effectively in a team environment
  • Self-motivated with demonstrated initiative and problem-solving abilities
  • Proficiency in Microsoft Office Suite; experience with electronic validation systems a plus
Working Conditions
  • On-site presence required; may involve work in manufacturing, laboratory, and utility areas
  • Ability to gown into cleanroom environments as required
  • Occasional flexibility in schedule and travel may be needed to support project timelines or production schedules
    #LI-TH1

er will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility, and process equipment.
At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
Company:
Design Group

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