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Computer System Validation Remote Jobs in Somerville, MA

Emvia, Inc.

Automation Validation Lead

Andover, MA · On-site +1

Automation Validation Lead Location : Andover, MA Duration - 6 months (possible extension ... computer system software and hardware: Windows operating systems Windows Terminal Services/Remote ...

BioNTech SE

Business Capability Specialist

Cambridge, MA · Remote

$113K - $181K/yr

Support GxP Computer System Validation activities by creating key documentation such as Validation Plans, User Requirements Specifications (URS), Testing Protocols (IQ/OQ/PQ/UAT), Traceability ...

Valspec

QA Consultant

Boston, MA · Remote

Valspec--a global provider of system validation and lifecycle services--provides commissioning and ... Remote Employment Type: Contract / Consulting (6-12+ months) Start Date: ASAP About the Role: We ...

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How much do computer system validation remote jobs pay per hour?

As of Jun 6, 2026, the average hourly pay for computer system validation remote in Somerville, MA is $59.28, according to ZipRecruiter salary data. Most workers in this role earn between $45.62 and $70.29 per hour, depending on experience, location, and employer.

What is computer system validation (CSV) in a remote job context?

Computer system validation (CSV) is a process used to ensure that IT systems and software used in regulated industries (such as pharmaceuticals or healthcare) work as intended and comply with relevant regulations. In a remote job context, CSV professionals perform validation tasks, documentation, and system testing from an offsite location, often collaborating with teams via digital tools. This remote work typically involves reviewing validation protocols, writing reports, and ensuring compliance with standards like FDA 21 CFR Part 11, all while leveraging secure online platforms to communicate and manage documentation.

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) professional working remotely, and why are they important?

To excel as a Computer System Validation Remote professional, you need a solid understanding of regulatory compliance (such as FDA 21 CFR Part 11), risk management, and validation lifecycle processes, often supported by a degree in computer science, engineering, or a related field. Familiarity with validation software, quality management systems (QMS), and documentation tools is typically required, along with certifications like GAMP or Six Sigma being advantageous. Strong attention to detail, analytical thinking, and effective remote communication are crucial soft skills for this role. These competencies ensure validated systems meet compliance standards, minimize risks, and support seamless collaboration in a regulated, distributed environment.

What is the difference between Computer System Validation Remote vs Computer System Validation on-site?

AspectComputer System Validation RemoteComputer System Validation on-site
Work EnvironmentPerforms validation tasks remotely, often from home or a different location from the client site.Works directly at the client or company site, conducting validation activities in person.
Required CredentialsTypically requires certifications like GxP, 21 CFR Part 11, and validation experience, applicable in both settings.Same certifications as remote roles, with additional familiarity with on-site equipment and facilities.
Industry UsageCommon in industries like pharmaceuticals and biotech where remote oversight is feasible.Traditional in regulated industries requiring on-site validation activities.

Both roles require similar certifications and industry knowledge, but the main difference lies in the work environment—remote versus on-site. Remote validation offers flexibility, while on-site validation involves direct interaction at the facility.

What are some common challenges faced by Computer System Validation professionals working remotely, and how can they be addressed?

Remote Computer System Validation (CSV) professionals often encounter challenges such as coordinating validation activities across distributed teams and ensuring secure access to sensitive documentation. Effective communication and use of collaborative tools are crucial for managing documentation reviews, test execution, and issue resolution. Establishing clear validation protocols and regular virtual check-ins with cross-functional teams can help maintain compliance and project momentum. Additionally, leveraging secure cloud-based validation platforms can streamline approvals and maintain data integrity while working remotely.
What job categories do people searching Computer System Validation Remote jobs in Somerville, MA look for? The top searched job categories for Computer System Validation Remote jobs in Somerville, MA are:
What cities near Somerville, MA are hiring for Computer System Validation Remote jobs? Cities near Somerville, MA with the most Computer System Validation Remote job openings:
Computer System Validation Remote jobs near you
Associate Director, Computer System Validation & Quality Compliance

Associate Director, Computer System Validation & Quality Compliance

Amylyx Pharmaceuticals

Cambridge, MA • On-site, Remote

Other

Posted 29 days ago

Job description

The Opportunity

The Associate Director, Computer System Validation (CSV) & Quality Compliance provides enterpriselevel leadership, strategic direction, and governance for the validation, lifecycle management, and continuous compliance of GxPrelevant computerized systems, with a strong emphasis on the Veeva Quality Suite. This role ensures that digital quality solutions and supporting systems meet global regulatory requirements (FDA, EMA, ICH, GAMP 5), maintain data integrity, and enable a sustainable, inspectionready state across the organization.

This person will partner closely with Quality, IT, Regulatory, Clinical, and business process owners to define system requirements, lead new system implementations and major enhancements, and drive harmonized, riskbased validation practices. This role also oversees quality compliance processes such as Change Control, Deviations, CAPA, and continuous improvement, ensuring timely closure, trend analysis, and effective governance through leadership of key forums including Quality Management Review and crossfunctional compliance meetings.

Responsibilities

Strategic Leadership & Governance

  • Develop, evolve, and steward the corporate CSV/CSA strategy, ensuring alignment with enterprise digital strategy and Quality Management System (QMS) objectives.
  • Serve as the senior Quality authority for computerized systems validation, data integrity, and electronic system compliance.
  • Oversee enterprise-wide governance programs, ensuring standardized, riskbased approaches to system implementation and maintenance.
  • Provide strategic guidance to senior leadership regarding system performance, risks, and compliance maturity.

Computer System Validation & Lifecycle Oversight

  • Lead planning, execution, review, and approval of validation deliverables across GxP systems.
  • Oversee system lifecycle activities including impact assessments, change management, periodic reviews, audit trails, user access reviews, and system retirement.
  • Promote and reinforce CSAaligned, riskbased validation practices to streamline compliance and maximize efficiency.
  • Ensure documentation quality and consistent application of SDLC principles across projects.

Veeva Systems Expertise & Optimization

  • Serve as the Quality SME for the Veeva Quality Suite, providing expert guidance on configuration, workflow optimization, and release readiness.
  • Lead implementation, enhancement, and optimization of Veeva Vault modules and crossfunctional integrations.
  • Drive automation and digitization initiatives that improve usability, compliance, and system performance.
  • Partner with IT and Veeva administrators to maintain robust, compliant change control processes.

Quality & Regulatory Compliance

  • Ensure all computerized systems maintain compliance with 21 CFR Part 11, EU Annex 11, GxP principles, and global data integrity expectations.
  • Author, revise, and own Quality System policies and procedures related to electronic systems and validation.
  • Represent Quality during internal audits, external regulatory inspections, and vendor assessments.
  • Lead timely remediation, effectiveness checks, and continuous improvement initiatives.
  • Provide oversight and trending for Quality Events related to system performance or compliance.

Required Qualifications

  • Bachelor's degree in a relevant scientific or technical discipline.
  • 8+ years of experience in the life sciences industry with strong GxP system experience.
  • Extensive leadership experience in cross functional implementation and validation of GxP computerized systems.
  • Deep expertise with Veeva Vault Quality Suite (QMS, Docs, Training, etc.).
  • Strong knowledge of global regulatory expectations and data integrity frameworks.
  • Demonstrated ability to lead enterprise programs, influence stakeholders, and drive compliant decision making.

Preferred Qualifications

  • Expertise with SaaS/cloud architectures and database compliance expectations.
  • Understanding of clinical data collection technologies and supporting data processes.
  • Familiarity with SDLC, Agile methodologies, CSV vs. CSA principles and automated testing platforms.
  • Experience developing and interpreting Quality metrics such as KPIs and KQIs.
  • Excellent communication skills with the ability to collaborate, negotiate, and influence at all organizational levels.

Work Location and Conditions

  • At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
  • You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving or public transportation.
  • You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communication via video conference, etc.) at your remote location.

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