Max Rate $$.$$$.$$ Onsite Princeton NJ 1. hands-on experience in Computer System Validation as a Validation Analyst/Lead working experience in GxP systems. 2. Hands on Applications knowledge on GxP ...
Max Rate $$.$$$.$$ Onsite Princeton NJ 1. hands-on experience in Computer System Validation as a Validation Analyst/Lead working experience in GxP systems. 2. Hands on Applications knowledge on GxP ...
Automation SME
Gaithersburg, MD · On-site
... system validation (CSV), and data integrity principles. • Experience leading automation system design, commissioning, qualification, troubleshooting, and lifecycle support. • Excellent ...
Automation SME
Gaithersburg, MD · On-site
... system validation (CSV), and data integrity principles. • Experience leading automation system design, commissioning, qualification, troubleshooting, and lifecycle support. • Excellent ...
Automation SME
Gaithersburg, MD · On-site
Working knowledge of GMP, GAMP 5, ISA-88, ISA-95, ISA/IEC 62443, ALCOA+, computerized system validation (CSV), and data integrity principles. Experience leading automation system design ...
Automation SME
Gaithersburg, MD · On-site
Working knowledge of GMP, GAMP 5, ISA-88, ISA-95, ISA/IEC 62443, ALCOA+, computerized system validation (CSV), and data integrity principles. Experience leading automation system design ...
Automation SME
Gaithersburg, MD · On-site
$120 - $180/hr
Working knowledge of GMP, GAMP 5, ISA-88, ISA-95, ISA/IEC 62443, ALCOA+,computerized system validation (CSV), and data integrity principles. * Experience leading automation system design ...
Automation SME
Gaithersburg, MD · On-site
$120 - $180/hr
Working knowledge of GMP, GAMP 5, ISA-88, ISA-95, ISA/IEC 62443, ALCOA+,computerized system validation (CSV), and data integrity principles. * Experience leading automation system design ...
Computer Security Systems Specialist (ITS14) Custom Computer Programming Services
Silver Spring, MD · On-site
$80 - $110/hr
... validation; system design; code generation; testing; deployment; and documentation. The Contractor shall also develop, support and evolve designs, customizations and process automation such as ...
Computer Security Systems Specialist (ITS14) Custom Computer Programming Services
Silver Spring, MD · On-site
$80 - $110/hr
... validation; system design; code generation; testing; deployment; and documentation. The Contractor shall also develop, support and evolve designs, customizations and process automation such as ...
Product Data Architect - Evinova
Gaithersburg, MD · On-site
$69 - $88.50/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Product Data Architect - Evinova
Gaithersburg, MD · On-site
$69 - $88.50/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Product Data Architect - Evinova
Gaithersburg, MD · On-site
$69 - $88.50/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Product Data Architect - Evinova
Gaithersburg, MD · On-site
$69 - $88.50/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Product Data Architect - Evinova
Gaithersburg, MD · On-site
$69 - $88.50/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Product Data Architect - Evinova
Gaithersburg, MD · On-site
$69 - $88.50/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Product Data Architect - Evinova
Gaithersburg, MD · On-site
$69 - $88.50/hr
... Computer Science, Computer Engineering, Mathematics, Information Science, or a related field 8+ ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Product Data Architect - Evinova
Gaithersburg, MD · On-site
$69 - $88.50/hr
... Computer Science, Computer Engineering, Mathematics, Information Science, or a related field 8+ ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Product Data Architect - Evinova
Gaithersburg, MD · On-site
$165.66 - $217.42/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or ...
Product Data Architect - Evinova
Gaithersburg, MD · On-site
$165.66 - $217.42/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or ...
Jr. Validation Engineer/QA Analyst/ Jr. QA Tester
Baltimore, MD · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. Description : WE ARE LOOKING FOR FRESH GRADUATES FOR QA and Validation POSITIONS.
Jr. Validation Engineer/QA Analyst/ Jr. QA Tester
Baltimore, MD · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. Description : WE ARE LOOKING FOR FRESH GRADUATES FOR QA and Validation POSITIONS.
Jr. Validation Engineer/QA Analyst/ Jr. QA Tester
Baltimore, MD · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. Description : WE ARE LOOKING FOR FRESH GRADUATES FOR QA and Validation POSITIONS.
Jr. Validation Engineer/QA Analyst/ Jr. QA Tester
Baltimore, MD · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. Description : WE ARE LOOKING FOR FRESH GRADUATES FOR QA and Validation POSITIONS.
Jr QA Tester
Mount Rainier, MD · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...
Jr QA Tester
Mount Rainier, MD · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...
Jr QA Tester
Mount Rainier, MD · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...
Jr QA Tester
Mount Rainier, MD · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...
Computer Systems Analyst
Rockville, MD · On-site
$98 - $163/hr
The electronic chemical inventory system is the central critical component to this process, and the ... Knowledge of software license management, upgrades, patches, and compatibility validation.
Computer Systems Analyst
Rockville, MD · On-site
$98 - $163/hr
The electronic chemical inventory system is the central critical component to this process, and the ... Knowledge of software license management, upgrades, patches, and compatibility validation.
Computer Systems Analyst
$98K - $163K/yr
The electronic chemical inventory system is the central critical component to this process, and the ... Knowledge of software license management, upgrades, patches, and compatibility validation.
Computer Systems Analyst
$98K - $163K/yr
The electronic chemical inventory system is the central critical component to this process, and the ... Knowledge of software license management, upgrades, patches, and compatibility validation.
Computer Systems Analyst
Rockville, MD · On-site
$98K - $163K/yr
The electronic chemical inventory system is the central critical component to this process, and the ... Knowledge of software license management, upgrades, patches, and compatibility validation.
Computer Systems Analyst
Rockville, MD · On-site
$98K - $163K/yr
The electronic chemical inventory system is the central critical component to this process, and the ... Knowledge of software license management, upgrades, patches, and compatibility validation.
Computer Systems Analyst
Woodlawn, MD · On-site
$35 - $42/hr
Write functional and system requirements covering web front-end, database, web services, RESTful ... Familiarity with prompt engineering for generating and validating test cases, acceptance criteria ...
Quick apply
Computer Systems Analyst
Woodlawn, MD · On-site
$35 - $42/hr
Write functional and system requirements covering web front-end, database, web services, RESTful ... Familiarity with prompt engineering for generating and validating test cases, acceptance criteria ...
Computer Systems Analyst
Woodlawn, MD · On-site
$35 - $42/hr
Write functional and system requirements covering web front-end, database, web services, RESTful ... Familiarity with prompt engineering for generating and validating test cases, acceptance criteria ...
Computer Systems Analyst
Woodlawn, MD · On-site
$35 - $42/hr
Write functional and system requirements covering web front-end, database, web services, RESTful ... Familiarity with prompt engineering for generating and validating test cases, acceptance criteria ...
The Paycor HRIS Administrator contractor will work closely with HR, Payroll, and the management ... Clean, organize, and validate data before it is moved into Excel, CSV files, Microsoft Fabric, or ...
Quick apply
The Paycor HRIS Administrator contractor will work closely with HR, Payroll, and the management ... Clean, organize, and validate data before it is moved into Excel, CSV files, Microsoft Fabric, or ...
Computer System Validation Csv information
What is a computer system validation CSV?
A Computer System Validation (CSV) job involves ensuring that computerized systems used in regulated industries, such as pharmaceuticals and medical devices, comply with industry standards and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). CSV professionals develop validation protocols, conduct testing, and document system performance to ensure data integrity, reliability, and compliance. Their role is critical in maintaining system quality and avoiding regulatory risks.
What are the key skills and qualifications needed to thrive in computer system validation CSV?
To thrive as a Computer System Validation (CSV) professional, you need a solid understanding of computer science, regulatory compliance (such as FDA 21 CFR Part 11), and validation methodology, often supported by a degree in a scientific or technical field. Familiarity with documentation tools, validation protocols, and quality management systems, as well as certifications like PMP or Six Sigma, is highly beneficial. Strong attention to detail, problem-solving abilities, and effective communication skills enable effective cross-functional collaboration. Mastering these skills ensures accurate validation processes, regulatory compliance, and smooth project execution in highly regulated environments.
What are some typical challenges faced by computer system validation CSV professionals and how are they addressed?
Computer System Validation (CSV) professionals often encounter challenges such as keeping up with evolving regulations, managing complex documentation requirements, and ensuring robust communication between IT, quality assurance, and business teams. Navigating system upgrades while maintaining compliance with strict regulatory standards requires careful planning and thorough risk assessment. Successful candidates address these challenges by staying current with industry guidance, utilizing validation templates and checklists, and fostering strong teamwork across various departments. Building collaborative relationships and maintaining meticulous records help ensure both audit readiness and smooth project completion.
Is computer system validation a good field?
Computer System Validation (CSV) is a specialized field within regulated industries like pharmaceuticals and biotech, focusing on ensuring software and systems meet compliance standards such as GxP. It offers opportunities for professionals with skills in quality assurance, validation protocols, and regulatory requirements, often requiring certifications like GAMP or 21 CFR Part 11 knowledge. The field provides stable employment with growth potential, especially as compliance regulations become more stringent.
What are the most commonly searched types of Computer System Validation Csv jobs in Maryland?
The most popular types of Computer System Validation Csv jobs in Maryland are:
What are popular job titles related to Computer System Validation Csv jobs in Maryland?
For Computer System Validation Csv jobs in Maryland, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Csv jobs in Maryland look for?
The top searched job categories for Computer System Validation Csv jobs in Maryland are:
- Full Time Computer System Validation Csv
- Engineer Syncade Or Pharmasuite Mes System
- Pcie Engineer
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- Computer System Validation Csv Pharmaceutical
- Biotech Csv
- Medical Device Validation Engineer
Quality Engineering & Assurance - Delivery - Test Lead - QDE118
Rockville, MD • On-site
Contractor
This job post has expired today. Applications are no longer accepted.
Job description
Job Description: Max Rate $$.$$$.$$
Onsite Princeton NJ
Job Description:
1. hands-on experience in Computer System Validation as a Validation Analyst/Lead working experience in GxP systems.
2. Hands on Applications knowledge on GxP systems such - Argus, Documentum, TrackWise
3. Experience working in Medical Device software systems
4. GAMP5 Risk based testing, IQ, OQ, PQ
5 Client Facing experience, work as independently and as a team member
Top 3 Must Haves:
1. Computer System Validation hands on end to end experience and knowledge
2. R&D GxP systems
3. HP ALM or similar application
Min 8 years
Additional Sills: Skills:
Category
Name
Required
Importance
Experience
No items to display.
Onsite Princeton NJ
Job Description:
1. hands-on experience in Computer System Validation as a Validation Analyst/Lead working experience in GxP systems.
2. Hands on Applications knowledge on GxP systems such - Argus, Documentum, TrackWise
3. Experience working in Medical Device software systems
4. GAMP5 Risk based testing, IQ, OQ, PQ
5 Client Facing experience, work as independently and as a team member
Top 3 Must Haves:
1. Computer System Validation hands on end to end experience and knowledge
2. R&D GxP systems
3. HP ALM or similar application
Min 8 years
Additional Sills: Skills:
Category
Name
Required
Importance
Experience
No items to display.
About First Soft Solutions
Sourced by ZipRecruiter
First Soft Solutions custom application Development and Maintenance Services are designed to enable you to lower the total cost of ownership and the required quality for your application. While all application Development Outsourcing is Technically custom, The difference is that packaged applications were designed with a general set of features to be used by a broad range of users. Custom application development is capable of producing practically any feature you may desire for your site. Time and money are virtually the only limiting factors. Our goal is to provide Clients with the Solution that fits their specific and unique needs while giving them the knowledge they need to operate and maintain the New Systems and Software. Our allegiance is to the best solution for our Clients. Our experience and knowledgeable consultants are ready to go above and beyond expectations to assist you in obtaining your goals. We can also provides expert project management throughout the entire project life cycle.
Industry
It services
Company size
11 - 50 Employees
Headquarters location
East Brunswick, NJ, US
Year founded
2006