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Computer System Validation Csv Remote Jobs in Minnesota

Maximus

System Test Engineer

Plymouth, MN · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Duluth, MN · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Saint Cloud, MN · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Rochester, MN · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Minneapolis, MN · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

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Computer System Validation Csv Remote information

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.

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

Validation Lead

Integrated Resources INC

Brooklyn Park, MN • On-site, Remote

Contractor

Posted 2 days ago

Job description

Company Description

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

OBJECTIVES:

Lead and manage validation projects. This role coordinates, supports and assists all aspects of a computerized systems validation project from original concept through the final implementation.

Develops project budgets and manages performance against financial parameters

ACCOUNTABILITIES:

The validation project manager will lead the overall validation activities on the project, and provide subject matter expertise in the area of computerized systems validation.

Lead and manage the overall validation testing activities and the validation testers on the project.

Support the development and execution of validation test scripts, user acceptance test scripts, IQs, OQs, and PQs.

Develop the overall project validation plan, validation report, and other validation life cycle documents. Assures quality, timeliness and effectiveness of deliverables while providing accurate status information to customers and IS/IT Leadership.

Assist in the development of computer systems validation policies and standards.

Participate in risk assessment exercises in support of validation activities, and perform periodic reviews.

Maintain knowledge and comprehensive understanding of relevant pharmaceutical regulations and current interpretations affecting computerized systems validation.

Represent Client during FDA or other regulatory agency inspections involving computer validation, electronic record/electronic signature, and data integrity.

Initiate process improvements to reduce software development, acquisition, and validation costs and cycle times.

Participate in the development of an audit plan for internal computer systems and external vendors and sites focused on the quality of the electronic data, systems, or services. This can be accomplished independently, or in support of other functions.

Participate in the development and implementation of strategies, processes, tools and techniques to identify areas for improvement within the electronic data, systems, and services environment, and implement action plans for implementing improvements.

Ensure that comprehensive software vendor audit assessments are performed for newly identified or current, regulated software vendors.

Assure projects / requests are appropriately prioritized and aligned with the strategy and direction of the organization and appropriate resources are allocated for their development.

Manages relationships with multiple vendors.

Qualifications

Bachelors Degree or high school degree and 8 years of work experience in any business related field.

Minimum of five years IT experience in a health agency regulated environment.

Experience with validated computer systems

Experience with planning and managing all phases of project development (e.g., requirements gathering, design, configuration, development, COTS selection, testing, conversion and application support

Additional Information

Kind Regards,

Daniel Jagota

Technical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT  732-429-1919 

daniel @irionline.com



Integrated Resources logo

About Integrated Resources

Sourced by ZipRecruiter

Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Edison, NJ, US

Year founded

1996

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