Validation (CSA/CSV) Consultant Location: Wichita, KS Job Type: Full-Time Experience Level: 1-8+ ... Ensure software and computer systems meet quality, safety, and regulatory standards. * Identify ...
Validation (CSA/CSV) Consultant Location: Wichita, KS Job Type: Full-Time Experience Level: 1-8+ ... Ensure software and computer systems meet quality, safety, and regulatory standards. * Identify ...
Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...
Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...
Labcorp is seekinga Computer System and Desktop Support Specialist to join its team! This position ... Assistas smart hands for IT hardware installations and validations all is working as expected
Labcorp is seekinga Computer System and Desktop Support Specialist to join its team! This position ... Assistas smart hands for IT hardware installations and validations all is working as expected
Labcorp is seeking a Computer System and Desktop Support Specialist to join its team! This position ... validations all is working as expected * Manage tickets for Issues and projects in ServiceNow ...
Labcorp is seeking a Computer System and Desktop Support Specialist to join its team! This position ... validations all is working as expected * Manage tickets for Issues and projects in ServiceNow ...
Recommend system improvements and validate new features. * Provide support to develop new product ... Excellent computer skills * Some travel may be required. Why Work at CAMP? Join a culture where ...
Recommend system improvements and validate new features. * Provide support to develop new product ... Excellent computer skills * Some travel may be required. Why Work at CAMP? Join a culture where ...
Recommend system improvements and validate new features. * Provide support to develop new product ... Excellent computer skills * Some travel may be required. Why Work at CAMP? Join a culture where ...
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Recommend system improvements and validate new features. * Provide support to develop new product ... Excellent computer skills * Some travel may be required. Why Work at CAMP? Join a culture where ...
EHM Analyst
Wichita, KS · On-site
Recommend system improvements and validate new features. * Provide support to develop new product ... Excellent computer skills * Some travel may be required. Why Work at CAMP? Join a culture where ...
EHM Analyst
Wichita, KS · On-site
Recommend system improvements and validate new features. * Provide support to develop new product ... Excellent computer skills * Some travel may be required. Why Work at CAMP? Join a culture where ...
Appraiser II
El Dorado, KS · On-site
$20.41 - $28.58/hr
... validation, new construction, and to remain in compliance with state statute; * Performs splits and combination of parcels in computer system; * Tracks new construction according to state statues;
Appraiser II
El Dorado, KS · On-site
$20.41 - $28.58/hr
... validation, new construction, and to remain in compliance with state statute; * Performs splits and combination of parcels in computer system; * Tracks new construction according to state statues;
Sr. CAD Survey Technician
Wichita, KS · On-site
Understands advanced CAD principles and techniques regarding scaling, geographic coordinate systems ... CST) * A valid drivers license must be maintained and insurable * Survey operations and survey ...
Sr. CAD Survey Technician
Wichita, KS · On-site
Understands advanced CAD principles and techniques regarding scaling, geographic coordinate systems ... CST) * A valid drivers license must be maintained and insurable * Survey operations and survey ...
Understands advanced CAD principles and techniques regarding scaling, geographic coordinate systems ... CST) * A valid drivers license must be maintained and insurable * Survey operations and survey ...
Understands advanced CAD principles and techniques regarding scaling, geographic coordinate systems ... CST) * A valid drivers license must be maintained and insurable * Survey operations and survey ...
... valid assessment tools * Works with ISD tools and licenses to meet current and projected program ... Simulator High Bay area computer rooms and OFT simulator/training devices. Physical Demands The ...
... valid assessment tools * Works with ISD tools and licenses to meet current and projected program ... Simulator High Bay area computer rooms and OFT simulator/training devices. Physical Demands The ...
Logistics Coordinator
Park City, KS · On-site
$17.50 - $23.25/hr
Make receiving, inventory, and purchase-order transactions in the company computer system ... Valid Kansas driver's license required * Must be capable of obtaining a Class B commercial driver ...
Logistics Coordinator
Park City, KS · On-site
$17.50 - $23.25/hr
Make receiving, inventory, and purchase-order transactions in the company computer system ... Valid Kansas driver's license required * Must be capable of obtaining a Class B commercial driver ...
... valid assessment tools * Works with ISD tools and licenses to meet current and projected program ... Simulator High Bay area computer rooms and OFT simulator/training devices. Physical Demands The ...
... valid assessment tools * Works with ISD tools and licenses to meet current and projected program ... Simulator High Bay area computer rooms and OFT simulator/training devices. Physical Demands The ...
Assistant Manager
Wichita, KS · On-site
$15/hr
Must have valid driver's license and good driving record. Essential Physical Requirements: (Some ... computer system and POS register system Ability to communicate with associates and guests Ability ...
Assistant Manager
Wichita, KS · On-site
$15/hr
Must have valid driver's license and good driving record. Essential Physical Requirements: (Some ... computer system and POS register system Ability to communicate with associates and guests Ability ...
Control Systems Specialist I
Colwich, KS · On-site
POSITION PURPOSE The Control System Specialist I position will design and implement PLC and DCS ... Install software and computer equipment at the various plant locations ensuring proper installation ...
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Control Systems Specialist I
Colwich, KS · On-site
POSITION PURPOSE The Control System Specialist I position will design and implement PLC and DCS ... Install software and computer equipment at the various plant locations ensuring proper installation ...
Control Systems Specialist I
Colwich, KS · On-site
POSITION PURPOSE The Control System Specialist I position will design and implement PLC and DCS ... Install software and computer equipment at the various plant locations ensuring proper installation ...
Quick apply
Control Systems Specialist I
Colwich, KS · On-site
POSITION PURPOSE The Control System Specialist I position will design and implement PLC and DCS ... Install software and computer equipment at the various plant locations ensuring proper installation ...
A&P Mechanic
Wichita, KS · On-site
$21.50 - $28.25/hr
Understanding and able to use computer systems such as Corridor, ATP, Textron One View. * Use ... Must possess and maintain a current and valid license. * Must meet the requirements of Airport ...
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A&P Mechanic
Wichita, KS · On-site
$21.50 - $28.25/hr
Understanding and able to use computer systems such as Corridor, ATP, Textron One View. * Use ... Must possess and maintain a current and valid license. * Must meet the requirements of Airport ...
... computer hardware, fiber optic, and camera systems ... New installations as well as major system renovations are made by this department when dictated by ...
... computer hardware, fiber optic, and camera systems ... New installations as well as major system renovations are made by this department when dictated by ...
... computer hardware, fiber optic, and camera systems ... New installations as well as major system renovations are made by this department when dictated by ...
... computer hardware, fiber optic, and camera systems ... New installations as well as major system renovations are made by this department when dictated by ...
... computer hardware, fiber optic, and camera systems ... New installations as well as major system renovations are made by this department when dictated by ...
... computer hardware, fiber optic, and camera systems ... New installations as well as major system renovations are made by this department when dictated by ...
Computer System Validation Csv information
See Wichita, KS salary details
$26.45 - $30.20
4% of jobs
$30.20 - $33.96
18% of jobs
$34.82 is the 25th percentile. Wages below this are outliers.
$33.96 - $37.71
13% of jobs
$37.71 - $41.47
14% of jobs
The median wage is $42.09 / hr.
$41.47 - $45.22
9% of jobs
$45.22 - $48.97
5% of jobs
$48.97 - $52.73
7% of jobs
$52.73 - $56.48
4% of jobs
$56.58 is the 75th percentile. Wages above this are outliers.
$56.48 - $60.23
9% of jobs
$60.23 - $63.99
12% of jobs
$63.99 - $67.74
4% of jobs
$26
$46
$67
How much do computer system validation csv jobs pay per hour?
What are the key skills and qualifications needed to thrive in the Computer System Validation Csv position, and why are they important?
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 is a Computer System Validation (CSV) job?
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 some typical challenges faced by Computer System Validation 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.

Full-time
Medical, Dental, Vision, Retirement
Posted 16 days ago
Job description
Job Type: Full-Time
Experience Level: 1-8+ Years
If you consider yourself a motivated and ambitious individual, this will be the job for you.
Arc Technologies Group serves companies from growth startups to the Fortune 50 within Life Sciences and Healthcare.
- Work on-site at ATG offices or Client offices or facilities on a daily basis
- This may involve a commute of up to 70 miles for extended periods of time
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Lead validation and qualification activities for computerized systems, applications, equipment, and infrastructure supporting regulated operations.
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Develop and execute validation lifecycle deliverables including Validation Plans, User Requirements Specifications (URS), Functional Specifications, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
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Apply risk-based validation methodologies consistent with GAMP 5, FDA Computer Software Assurance (CSA), and industry best practices.
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Facilitate requirements gathering sessions with business, quality, engineering, laboratory, and IT stakeholders.
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Review system design documentation to ensure compliance, data integrity, and validation requirements are appropriately addressed.
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Author, review, and execute validation test protocols and document test results, deviations, investigations, and corrective actions.
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Support implementation and validation of enterprise and manufacturing technologies, including MES, LIMS, ELN, ERP, SCADA, historian, automation, and laboratory systems.
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Assess and document system impacts related to change controls, software updates, infrastructure modifications, and periodic reviews.
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Support regulatory inspections, internal audits, client audits, and quality assurance reviews by providing validation documentation and compliance evidence.
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Collaborate with project teams to develop validation strategies, schedules, and resource plans.
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Ensure compliance with applicable regulations and standards including FDA, EU GMP Annex 11, GAMP 5, WHO, MHRA, and other relevant guidance. Ensure software and computer systems meet quality, safety, and regulatory standards.
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Identify validation risks and develop mitigation strategies to support successful project delivery.
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Participate in client-facing meetings, workshops, assessments, and strategic consulting engagements.
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Understand and develop (SDLC) system/software development lifecycle and technical validation documentation. Execute validation testing where appropriate for IT and OT systems.
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Produce or maintain accurate and up-to-date documentation for all IT and OT systems, including user manuals, standard operating procedures, work instructions, and validation protocols.
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Provide advice/consultation on validation documentation and system/user requirements to achieve the best possible testing outcomes.
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Think critically on test structures/design and ensure all client requirements are verified during validation.
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Have attention to detail and apply patience when producing or reviewing documentation to identify and fix errors.
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Put complex information into clear, concise, and accessible content/format for the intended audience. Ability to review, edit and proofread content for accuracy, clarity, and consistency.
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Research and gather information on systems/projects to fully understand operational function and use case. Includes working with SMEs and other teams to research and collect information needed for accurate documentation.
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Determine and analyze the needs of end users to ensure that all documentation and requirements are clear and tailored to the system.
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Learn and understand complex systems and topics quickly.
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Perform risk assessments on various systems
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Understand client requirements, business objectives amp; processes, in addition to their technology and systems
- Leverage your sales mindset to deepen customer relationships, help transform services into comprehensive solutions, and collaborate with the sales team to align goals with outcomes
- Identify expansion opportunities to drive growth and ensure customer satisfaction through innovative IT/OT, validation, engineering, and quality strategies
- Support new technology implementation and provide assistance with technical issues, strategic direction, and financial analysis of projects/initiatives
- Perform critical analysis of existing “People, Process, and Technology” state of clients
- Work collaboratively with cross-functional teams, including R amp;D, quality assurance, and manufacturing, to deliver IT/OT solutions that meet business needs
Minimum Qualifications:
- Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related technical discipline.
- Minimum of 2 years of experience in computerized systems validation (CSV), computer software assurance (CSA), commissioning and qualification (C amp;Q), or a related validation discipline within the pharmaceutical, biotechnology, medical device, or regulated healthcare industry.
- Strong understanding of FDA 21 CFR Part 11, GxP regulations, data integrity principles, and GAMP 5 guidance.
- Experience developing and executing validation lifecycle documentation including URS, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation reports.
- Experience supporting validation of GxP systems such as LIMS, MES, ERP, QMS, laboratory instruments, manufacturing execution systems, automation platforms, or cloud-based applications.
- Knowledge of software development lifecycle (SDLC), change management, configuration management, and quality management processes.
- Demonstrated ability to interpret regulatory requirements and translate them into practical validation strategies.
- Strong technical writing, documentation, analytical, and problem-solving skills.
- Excellent verbal and written communication skills with the ability to interact effectively with technical, quality, and business stakeholders.
- Ability to manage multiple projects and priorities in a fast-paced consulting environment
- Strong analytical and problem-solving skills, excellent communication and interpersonal skills, and the ability to work effectively in a team environment
- Employees will be expected to commute up to 70 miles each way per day to various client sites if working at a long-term client facility. This is not a remote position
- Employees must provide their own means of reliable transportation
- BYOD is expected, employees will be required to use a cell phone for work purposes including the installation of work communication tools such as MS Teams or Outlook
- Must be authorized to work in the United States.
- Candidates must be authorized to be employed in the U.S. by any employer.
- U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
- Must be available to work on-site in Wichita, KS during standard business hours (roughly 8am-5pm, Monday-Friday)
- This position is not remote; reliable daily transportation to our Wichita office and/or customer sites is required.
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Requires routine sitting, standing, walking, listening and talking
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Acute mental and visual attention at all times
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Ability to handle multiple projects while managing frequent interruptions
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Requires moderate lifting or moving up to 100 pounds (lbs)
- Experience with FDA Computer Software Assurance (CSA) methodology.
Knowledge of manufacturing automation platforms, OT systems, and industrial control systems.
Familiarity with cloud-hosted GxP systems and SaaS validation.
Previous consulting experience supporting multiple clients and projects.
Certifications such as ASQ Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), PMP, or relevant validation certifications.
Experience supporting regulatory inspections and remediation initiatives. - Understand or have previous knowledge/experience in using document management systems and/or electronic execution systems with workflow and versioning capabilities.
- Operational Technology foundational knowledge, including but not limited to experience with IIoT, PLCs, HMIs, SCADAs, etc.
- Familiarity with enterprise IT and OT cybersecurity architecture and/or frameworks
- Have the ability to troubleshoot hardware, software, and network problems amp; to think critically to analyze and remediate root causes
- ITIL Framework
- 401K
- Short-term/Long-term disability
- Medical/Dental/Vision may be available
- Opportunities for professional development and career advancement
- Collaborative amp; high-performance work environment
About Arc Technologies Group
Sourced by ZipRecruiter
Industry
It services
Company size
11 - 50 Employees
Headquarters location
Wichita, KS, US
Year founded
2013