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Computer System Validation Remote Jobs in Massachusetts

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 ...

Syner-G

Validation Engineer

Boston, MA · On-site +1

Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. * Hands ... We define total rewards as compensation, benefits, remote work/flexibility, development ...

Syner-G

Validation Engineer

Waltham, MA · On-site +1

Perform P&ID walkdowns to verify installation and system readiness. * Conduct thermal mapping of ... We define total rewards as compensation, benefits, remote work/flexibility, development ...

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 ...

Danaher

Senior Engineer, Process Validation

Boston, MA · On-site +1

$100K - $130K/yr

And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact ... We recognize the benefits of flexible, remote working arrangements for eligible roles and are ...

Cybercoders

Computer Vision Engineer

Cambridge, MA · On-site +1

$121K - $143K/yr

Computer Vision Engineer Computer Vision Engineer Remote in US Full-Time About the Opportunity We ... In this role, you will help develop and deploy production-ready machine learning systems, working ...

Cybercoders

AI/ML Engineer - Computer Vision

Cambridge, MA · On-site +1

$121K - $143K/yr

AI/ML Engineer - Computer Vision AI/ML Engineer - Computer Vision Remote in US Full-Time About the ... In this role, you will help develop and deploy production-ready machine learning systems, working ...

Revolution Space

Senior Software Systems Engineer

Boston, MA · On-site +1

$156K - $244K/yr

... remote. Responsibilities: * Establish and maintain software development, testing, and delivery ... Document and review system designs, procedures, and workflows * Design scripts and tools to improve ...

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Computer System Validation Remote information

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 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 Remote jobs in Massachusetts? For Computer System Validation Remote jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Remote jobs in Massachusetts look for? The top searched job categories for Computer System Validation Remote jobs in Massachusetts are:
What cities in Massachusetts are hiring for Computer System Validation Remote jobs? Cities in Massachusetts with the most Computer System Validation Remote job openings:
Computer System Validation Remote jobs near you
Automation Validation Lead

Automation Validation Lead

Emvia, Inc.

Andover, MA • On-site, Remote

Contractor

Re-posted 17 days ago

Job description

Company Description

Emvia Inc

Job Description

Position : Automation Validation Lead

Location : Andover, MA

Duration - 6 months (possible extension)


Interview mode- Local or regional candidates preferred. May be open to Skype for excellent candidate.

Job description:

The Automation Validation Lead is responsible for overseeing all automation testing (leveraged software Factory Acceptance Tests, Commissioning and Validation) to ensure successful validation of all automation systems
The Automation Validation Lead will report to the Automation Lead and additionally take direction from the Projects Validation Lead. The Automation Validation Lead will be an active member of the overall project team working with the team, Engineer of Record and Construction Manager.
Key Responsibilities:

Finalize the Automation Validation Plan
Work with a team of Engineers and System Integration (SI) contractors to complete all validation deliverables related to the Delta-V Manufacturing Control System (MCS) and Qualified Utilities Network (QUN)
Give guidance on validation best practices for automation hardware, software and computer systems.
Follow FDA Title 21 CFR Part 11 for Data Integrity Compliance
Draft, review or approve automation design and testing documents for all phases of testing (sFAT, Commissioning, Validation)
Drive deviation resolution for all testing
Requirements:

7 years of relevant automation validation experience
The candidate must have a strong background working in cGMP environments.
The candidate must have excellent communication skills.
Experience with Emerson Controllers and Emerson DeltaV Software is required.
The ideal candidate would have experience with the following hardware: Allen Bradley PLCs and I/O
o The ideal candidate would have experience with the following software: GEs Proficy FIX, OSISofts OSIPi or similar Historian software Reporting software, InfoBatch is preferred
The ideal candidate should be familiar with the following communication methods/protocols: Ethernet Profibus OPC
The ideal candidate should be familiar with the following computer system software and hardware: Windows operating systems Windows Terminal Services/Remote Desktop VMWare Dell VRTX familiarity is a plus
Limited local travel to software Factory Acceptance Tests (FATs) may be required
Work Location: Andover, MA
Over time may be required during peak times but the expectation is that the it will typically be a standard 40 hour work week.


Additional Information

All your information will be kept confidential according to EEO guidelines.

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About EMVIA

Sourced by ZipRecruiter

Industry

Software development

Company size

11 - 50 Employees

Headquarters location

Allen, TX, US

Year founded

2007

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