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Computer System Validation Csv Remote Jobs in Georgia

TIER4 GROUP

System Architect

Atlanta, GA · On-site +1

$233K/yr

System Architect Direct Hire Remote in CST or EST, preference is for local to Atlanta Position ... Requirements: · Bachelor's degree in Computer Science, Data Science, Engineering, or a related ...

Wayne Farms LLC

HR Systems Security Analyst

Oakwood, GA · Remote

HR Systems Security Analyst - THIS ROLE IS REMOTE Job Summary : The HR Systems Security Analyst ... Review security impacts for system updates, enhancements, and Workday releases. * Validate security ...

Harris

Travel is required as needed, approximately 10%. Candidates must hold a current, valid passport and ... Bachelor's degree in Geographic Information Systems, Computer Science, Geography, or a related ...

Harris

Travel is required as needed, approximately 10%. Candidates must hold a current, valid passport and ... Bachelor's degree in Geographic Information Systems, Computer Science, Geography, or a related ...

Kodama Systems Inc.

Remote Skidder Operator

Macon, GA · On-site +1

$20 - $30/hr

Kodama Systems is a technology company transforming the forestry industry with teleoperation and ... Valid U.S. Drivers License Compensation + Benefits: * $20-30 per hour, depending on experience

Lancesoft

IT Operations Support

Atlanta, GA · On-site +1

$20 - $30.85/hr

Working knowledge of computer systems/networks: Windows physical/virtual/clustered servers UNIX ... This position is for a hybrid/remote worker. The Infrastructure Operations Center is a 24x7x365 ...

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Computer System Validation Csv Remote information

What is a Computer System Validation (CSV) specialist and what do they do remotely?

A Computer System Validation (CSV) specialist is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards and function as intended. When working remotely, CSV specialists perform tasks like developing validation protocols, reviewing documentation, executing test scripts, and liaising with teams via digital tools to ensure systems adhere to regulatory guidelines. Their work helps guarantee data integrity, product quality, and regulatory compliance in industries where strict standards are critical.

What is the difference between Computer System Validation Csv Remote vs Computer Validation Specialist?

AspectComputer System Validation Csv RemoteComputer Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRemote, regulated industries like pharma and biotechOn-site or hybrid in regulated industries
Industry UsagePharmaceutical, biotech, medical devicesPharmaceutical, biotech, medical devices
Job FocusValidating computer systems and software complianceValidating computer systems and software compliance

Both roles require similar certifications and work in regulated industries like pharma and biotech. The main difference is that Computer System Validation Csv Remote typically involves remote work, focusing on validating computer systems remotely, while Computer Validation Specialist may work on-site or in hybrid settings. Both roles aim to ensure compliance with industry standards and regulations.

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

Remote CSV professionals often encounter challenges such as coordinating validation activities across different teams, ensuring secure access to validation environments, and maintaining clear documentation. Effective communication is key—using project management tools and regular virtual meetings helps keep everyone aligned. It's also important to implement robust cybersecurity measures and standardized documentation practices to ensure compliance. Proactively addressing these challenges fosters a smooth validation process and supports regulatory requirements.

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) specialist in a remote role, and why are they important?

To excel as a Computer System Validation (CSV) specialist, you need a solid background in computer science or life sciences, experience with GxP regulations, and knowledge of validation documentation standards. Familiarity with validation management tools, electronic quality management systems (eQMS), and understanding regulatory frameworks like FDA 21 CFR Part 11 or EU Annex 11 is crucial. Strong attention to detail, problem-solving skills, and effective remote communication set top performers apart. These competencies ensure validated systems meet compliance requirements, maintain data integrity, and support regulatory audits in remote environments.
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Computer System Validation Csv Remote jobs near you
System Architect

System Architect

TIER4 GROUP

Atlanta, GA • On-site, Remote

$233K/yr

Full-time

Re-posted 5 days ago

Job description

System Architect

Direct Hire

Remote in CST or EST, preference is for local to Atlanta

Position Details:

We are seeking a skilled and collaborative System Architect to join our team and help define and communicate a shared technical and architectural vision within the context of a Scaled Agile Framework (SAFe) environment. The ideal candidate will play a key role in aligning architectural design with business priorities, ensuring the implementation of a flexible and adaptable system architecture that supports the delivery of high-value solutions. This position works closely with Agile teams, Product Management, the Release Train Engineer (RTE), and Business Owners to ensure continuous alignment with business goals and optimal system performance.

Responsibilities:

Align Architecture with Business Priorities:

·       Define enablers and create an architectural runway to support upcoming features in the Agile Release Train (ART) backlog.

·       Participate in solution definition, providing insights into technological capabilities and constraints.

·       Define system Non-Functional Requirements (NFRs) and ensure architecture supports them.

·       Collaborate with Product Management to ensure sufficient capacity for enablement work during PI planning.

Define and Communicate Architecture Vision:

·       Present the architectural vision to Agile teams during PI Planning, adjusting as necessary based on new insights.

·       Provide continuous guidance on implementation and architectural flexibility to accommodate changes during development.

·       Use abstraction and set-based design to support system agility.

Evolve System Design with Teams:

·       Collaborate with Agile teams to uncover inconsistencies in design and make necessary adjustments.

·       Support architectural experiments and spikes to validate design assumptions efficiently.

·       Align architectural expectations with the reality of Agile team capacities, skills, and tools.

Foster Built-In Quality and Address NFRs:

·       Promote system design that supports built-in quality by facilitating early problem discovery, continuous testing, and maintenance.

·       Provide guidance to teams on addressing NFRs to ensure sustainability and minimize rework.

Support DevOps and Continuous Delivery Pipeline (CDP):

·       Help develop system architecture that supports incremental value delivery through the DevOps process and CDP.

·       Guide teams in choosing appropriate tools, environments, and infrastructure, incorporating scalable and adaptable solutions.

·       Enable metrics instrumentation for tracking performance, user behavior, and operational efficiency.

Requirements:

·       Bachelor's degree in Computer Science, Data Science, Engineering, or a related field (Master's preferred).

·       Proven experience in system architecture within an Agile framework (SAFe experience highly preferred).

·       Strong knowledge of architectural principles and tools for cloud solutions, data architecture, and system security.

·       Experience in DevOps and continuous delivery, with a focus on scalable infrastructure and cloud-based solutions.

·       Excellent communication skills with the ability to explain complex technical concepts to various stakeholders.