Senior CSV Engineer
Chicago, IL · On-site
$107K - $147K/yr
The Senior Computer System Validation (CSV) Engineer is responsible for leading validation ... Support system implementations, upgrades, and decommissioning activities from a validation ...
Senior CSV Engineer
Chicago, IL · On-site
$107K - $147K/yr
The Senior Computer System Validation (CSV) Engineer is responsible for leading validation ... Support system implementations, upgrades, and decommissioning activities from a validation ...
Senior Quality Engineer
Chicago, IL · On-site
Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ... is performed from California and may vary for other locations (Colorado, Illinois, New York)
Senior Quality Engineer
Chicago, IL · On-site
Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ... is performed from California and may vary for other locations (Colorado, Illinois, New York)
Senior Quality Engineer
Chicago, IL · On-site +1
Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ... is performed from California and may vary for other locations (Colorado, Illinois, New York)
Senior Quality Engineer
Chicago, IL · On-site +1
Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ... is performed from California and may vary for other locations (Colorado, Illinois, New York)
Computer Systems Technician II - Hardware
Buffalo Grove, IL · On-site
Medical
Dental
Vision
Life
Retirement
PTO
From small retailers looking to monitor foot traffic to large-scale smart cities deploying AI-based ... Conduct rigorous quality assurance inspections and system validation testing. * Mentor and train ...
Computer Systems Technician II - Hardware
Buffalo Grove, IL · On-site
Medical
Dental
Vision
Life
Retirement
PTO
From small retailers looking to monitor foot traffic to large-scale smart cities deploying AI-based ... Conduct rigorous quality assurance inspections and system validation testing. * Mentor and train ...
Engineer, Quality Assurance
Cary, IL · On-site
$52 - $54/hr
... from a legacy PLM platform, along with integration between the new PLM system and the Manufacturing Execution System. This is a project-based role focused on Computer System Validation, also known as ...
Engineer, Quality Assurance
Cary, IL · On-site
$52 - $54/hr
... from a legacy PLM platform, along with integration between the new PLM system and the Manufacturing Execution System. This is a project-based role focused on Computer System Validation, also known as ...
Electronic Systems Verification & Validation Project Team Leader
Mossville, IL · On-site
$128K - $192K/yr
Medical
Dental
Vision
Life
Retirement
PTO
... from requirements through SIL validation to HIL and system integration testing * Lead and mentor a ... Bachelor's degree in engineering or computer science * Typically, have 7+ years' experience in ...
Electronic Systems Verification & Validation Project Team Leader
Mossville, IL · On-site
$128K - $192K/yr
Medical
Dental
Vision
Life
Retirement
PTO
... from requirements through SIL validation to HIL and system integration testing * Lead and mentor a ... Bachelor's degree in engineering or computer science * Typically, have 7+ years' experience in ...
Electronic Systems Verification & Validation Project Team Leader
Mossville, IL · On-site
$128.47 - $192.71/hr
Medical
Dental
Vision
Life
Retirement
PTO
... from requirements through SIL validation to HIL and system integration testing * Lead and mentor a ... Bachelor's degree in engineering or computer science * Typically, have 7+ years' experience in ...
New
Electronic Systems Verification & Validation Project Team Leader
Mossville, IL · On-site
$128.47 - $192.71/hr
Medical
Dental
Vision
Life
Retirement
PTO
... from requirements through SIL validation to HIL and system integration testing * Lead and mentor a ... Bachelor's degree in engineering or computer science * Typically, have 7+ years' experience in ...
New
Commissioning, Qualification, and Validation Lead (Pharmaceutical - Construction)
Virginia, IL · On-site
$115K - $161K/yr
Medical
Dental
Vision
Retirement
PTO
Manage system and subsystem turnover from construction through qualification. * Review turnover ... Computer System Validation, data integrity, and 21 CFR Part 11. Preferred Education and Experience:
Commissioning, Qualification, and Validation Lead (Pharmaceutical - Construction)
Virginia, IL · On-site
$115K - $161K/yr
Medical
Dental
Vision
Retirement
PTO
Manage system and subsystem turnover from construction through qualification. * Review turnover ... Computer System Validation, data integrity, and 21 CFR Part 11. Preferred Education and Experience:
Computer Systems Technician II - Hardware
Buffalo Grove, IL · On-site
$17.50 - $23.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
From small retailers looking to monitor foot traffic to large-scale smart cities deploying AI-based ... Conduct rigorous quality assurance inspections and system validation testing. * Mentor and train ...
Computer Systems Technician II - Hardware
Buffalo Grove, IL · On-site
$17.50 - $23.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
From small retailers looking to monitor foot traffic to large-scale smart cities deploying AI-based ... Conduct rigorous quality assurance inspections and system validation testing. * Mentor and train ...
Senior Information Systems Project Manager
Cary, IL · On-site
$66.66/hr
Medical
Dental
Vision
Life
Retirement
Lead User Acceptance Testing and manage Computer System Validation lifecycle. * Serve as primary ... Experience managing data migration from legacy systems * Strong understanding of system integration ...
Quick apply
Senior Information Systems Project Manager
Cary, IL · On-site
$66.66/hr
Medical
Dental
Vision
Life
Retirement
Lead User Acceptance Testing and manage Computer System Validation lifecycle. * Serve as primary ... Experience managing data migration from legacy systems * Strong understanding of system integration ...
Senior Information Systems Project Manager
Cary, IL · On-site
$66.66/hr
Medical
Dental
Vision
Life
Retirement
Lead User Acceptance Testing and manage Computer System Validation lifecycle. * Serve as primary ... Experience managing data migration from legacy systems * Strong understanding of system integration ...
Quick apply
Senior Information Systems Project Manager
Cary, IL · On-site
$66.66/hr
Medical
Dental
Vision
Life
Retirement
Lead User Acceptance Testing and manage Computer System Validation lifecycle. * Serve as primary ... Experience managing data migration from legacy systems * Strong understanding of system integration ...
Senior Information Systems Project Manager
Cary, IL · On-site
$66.66/hr
Medical
Dental
Vision
Life
Retirement
Lead User Acceptance Testing and manage Computer System Validation lifecycle. * Serve as primary ... Experience managing data migration from legacy systems * Strong understanding of system integration ...
Quick apply
Senior Information Systems Project Manager
Cary, IL · On-site
$66.66/hr
Medical
Dental
Vision
Life
Retirement
Lead User Acceptance Testing and manage Computer System Validation lifecycle. * Serve as primary ... Experience managing data migration from legacy systems * Strong understanding of system integration ...
Senior Information Systems Project Manager
Cary, IL · On-site
$66.66/hr
Medical
Dental
Vision
Life
Retirement
Lead User Acceptance Testing and manage Computer System Validation lifecycle. * Serve as primary ... Experience managing data migration from legacy systems * Strong understanding of system integration ...
Quick apply
Senior Information Systems Project Manager
Cary, IL · On-site
$66.66/hr
Medical
Dental
Vision
Life
Retirement
Lead User Acceptance Testing and manage Computer System Validation lifecycle. * Serve as primary ... Experience managing data migration from legacy systems * Strong understanding of system integration ...
Manager, Facilities & Software Validations
Rockford, IL · On-site
Medical
Dental
Vision
Retirement
PTO
In-depth knowledge of Computer System Validation (CSV) and GAMP 5 methodology. * Working knowledge of FDA regulations (21 CFR Parts 820, 210/211, and 11). * Full Professional Proficiency: Ability to ...
Manager, Facilities & Software Validations
Rockford, IL · On-site
Medical
Dental
Vision
Retirement
PTO
In-depth knowledge of Computer System Validation (CSV) and GAMP 5 methodology. * Working knowledge of FDA regulations (21 CFR Parts 820, 210/211, and 11). * Full Professional Proficiency: Ability to ...
Manager, Facilities & Software Validations
Rockford, IL · On-site
Medical
Dental
Vision
Retirement
PTO
In-depth knowledge of Computer System Validation (CSV) and GAMP 5 methodology. * Working knowledge of FDA regulations (21 CFR Parts 820, 210/211, and 11). * Full Professional Proficiency: Ability to ...
Manager, Facilities & Software Validations
Rockford, IL · On-site
Medical
Dental
Vision
Retirement
PTO
In-depth knowledge of Computer System Validation (CSV) and GAMP 5 methodology. * Working knowledge of FDA regulations (21 CFR Parts 820, 210/211, and 11). * Full Professional Proficiency: Ability to ...
Validation Engineer
Round Lake, IL · On-site
We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. * The role involves planning and executing V&V ...
Validation Engineer
Round Lake, IL · On-site
We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. * The role involves planning and executing V&V ...
Computer Systems Validation (Software Quality Assurance - CSV) Chicago area Long Term Contract rate ... MVP, Risk) * Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release)
Computer Systems Validation (Software Quality Assurance - CSV) Chicago area Long Term Contract rate ... MVP, Risk) * Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release)
Computer Systems Technician II - Hardware
Buffalo Grove, IL · On-site
Medical
Dental
Vision
Life
Retirement
PTO
From small retailers looking to monitor foot traffic to large-scale smart cities deploying AI-based ... Conduct rigorous quality assurance inspections and system validation testing. * Mentor and train ...
Quick apply
Computer Systems Technician II - Hardware
Buffalo Grove, IL · On-site
Medical
Dental
Vision
Life
Retirement
PTO
From small retailers looking to monitor foot traffic to large-scale smart cities deploying AI-based ... Conduct rigorous quality assurance inspections and system validation testing. * Mentor and train ...
IT Business Systems Analyst
Mundelein, IL · On-site
Computer System Validation ( CSV ). * Data integrity, audit trails, archiving, and retention. * Advanced analytics, machine learning, or predictive Quality analytics.
New
IT Business Systems Analyst
Mundelein, IL · On-site
Computer System Validation ( CSV ). * Data integrity, audit trails, archiving, and retention. * Advanced analytics, machine learning, or predictive Quality analytics.
New
JR QA TESTER
Evanston, IL · On-site
$55K - $58K/yr
Medical
Dental
... Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON ... clients from a broad range of Industries. ITE is an end-to-end global consulting & solutions ...
JR QA TESTER
Evanston, IL · On-site
$55K - $58K/yr
Medical
Dental
... Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON ... clients from a broad range of Industries. ITE is an end-to-end global consulting & solutions ...
From Home Computer System Validation information
What is the difference between From Home Computer System Validation vs From Home Quality Assurance Specialist?
| Aspect | From Home Computer System Validation | From Home Quality Assurance Specialist |
|---|---|---|
| Certifications | GxP validation, 21 CFR Part 11 | ISO 9001, QA certifications |
| Work Environment | Primarily remote, focused on system testing and validation | Remote or onsite, focused on process audits and compliance |
| Industry Usage | Pharmaceutical, biotech, healthcare | Manufacturing, software, healthcare |
| Job Focus | Ensuring computer systems meet regulatory standards | Ensuring overall quality processes and compliance |
From Home Computer System Validation primarily involves verifying that computer systems meet regulatory standards, especially in healthcare and biotech industries. In contrast, From Home Quality Assurance Specialist focuses on broader quality processes and compliance across various industries. Both roles may be remote and require similar certifications, but their core responsibilities differ in scope and focus.
What are the most commonly searched types of Computer System Validation jobs in Illinois?
The most popular types of Computer System Validation jobs in Illinois are:
What are popular job titles related to From Home Computer System Validation jobs in Illinois?
For From Home Computer System Validation jobs in Illinois, the most frequently searched job titles are:
What job categories do people searching From Home Computer System Validation jobs in Illinois look for?
The top searched job categories for From Home Computer System Validation jobs in Illinois are:
What cities in Illinois are hiring for From Home Computer System Validation jobs?
Cities in Illinois with the most From Home Computer System Validation job openings:
$107K - $147K/yr
Other
Posted 5 days ago
Job description
Job Description:
The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.
Responsibilities:
The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.
Responsibilities:
- Lead and execute computer system validation (CSV) activities for GxP-regulated systems.
- Develop and review validation deliverables including validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports.
- Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP regulations.
- Define and implement risk-based validation strategies for computerized systems.
- Oversee validation of systems such as LIMS, ELN, MES, ERP, CDS, and laboratory systems.
- Support system implementations, upgrades, and decommissioning activities from a validation perspective.
- Collaborate with IT, QA, Engineering, and business stakeholders to ensure compliant system deployment.
- Lead change control assessments and determine validation impact of system changes.
- Ensure data integrity (ALCOA+) compliance across validated systems.
- Support audits and regulatory inspections by providing validation documentation and system justification.
- Mentor and guide junior CSV engineers and validation team members.
- Drive continuous improvement of validation processes, templates, and standards.
- Review vendor documentation and ensure systems meet regulatory expectations prior to deployment.
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
- 5-10+ years of experience in Computer System Validation (CSV) or validation engineering.
- Strong experience in GxP-regulated pharmaceutical, biotech, or medical device environments.
- Hands-on experience with validation of LIMS, MES, ERP, or laboratory systems.
- Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
- Experience authoring and executing IQ/OQ/PQ protocols and validation documentation.
- Strong understanding of risk-based validation and data integrity principles.
- Experience supporting regulatory audits and inspections.
- Experience with systems such as LabWare, SAP, Oracle, Veeva, TrackWise, Empower.
- Knowledge of cloud-based validation and SaaS systems.
- Experience in data integrity remediation projects.
- Strong technical writing and documentation skills.
- bility to lead cross-functional validation projects.
- Strong leadership and SME-level expertise in CSV.
- Excellent analytical and risk assessment skills.
- Strong communication and stakeholder management.
- bility to manage multiple validation projects simultaneously.
- High attention to detail and regulatory compliance mindset.