Senior Quality Engineer
Chicago, IL · On-site
Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements. Responsibilities: * Support ...
Senior Quality Engineer
Chicago, IL · On-site
Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements. Responsibilities: * Support ...
Senior Quality Engineer
Chicago, IL · On-site +1
Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements. Responsibilities: * Support ...
Senior Quality Engineer
Chicago, IL · On-site +1
Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements. Responsibilities: * Support ...
Validation Engineer (CQV, GMP, Life Sciences)
Chicago, IL · On-site
$70K - $100K/yr
... Computer System Validation, CSV Engineer, FDA Compliance, GMP Engineer Please visit our careers page to see more job opportunities.
Validation Engineer (CQV, GMP, Life Sciences)
Chicago, IL · On-site
$70K - $100K/yr
... Computer System Validation, CSV Engineer, FDA Compliance, GMP Engineer Please visit our careers page to see more job opportunities.
Experience with Computer System Validation (CSV) and GxP regulations. Knowledge of FDA 21 CFR Part 11, EU GMP, and Annex 11 compliance requirements. Experience in SAP documentation, SOPs, validation ...
Experience with Computer System Validation (CSV) and GxP regulations. Knowledge of FDA 21 CFR Part 11, EU GMP, and Annex 11 compliance requirements. Experience in SAP documentation, SOPs, validation ...
Engineer, Validation Commissioning
North Chicago, IL · On-site
$65K/yr
Experience with Computer System Validation (CSV) is required. * 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment ...
Engineer, Validation Commissioning
North Chicago, IL · On-site
$65K/yr
Experience with Computer System Validation (CSV) is required. * 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment ...
Experience with Computer System Validation (CSV) is required. * 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment ...
Quick apply
Experience with Computer System Validation (CSV) is required. * 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment ...
Experience with Computer System Validation (CSV) is required. * 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment ...
Experience with Computer System Validation (CSV) is required. * 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment ...
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 ...
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 ...
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 ...
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 ...
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)
IL · On-site
Familiarity with computerized systems validation (CSV), cleaning validation, or utility qualification is an added advantage. I am actively connecting with professionals for current and upcoming ...
Quick apply
IL · On-site
Familiarity with computerized systems validation (CSV), cleaning validation, or utility qualification is an added advantage. I am actively connecting with professionals for current and upcoming ...
System Test and Validation Lead
Chicago, IL · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Chicago, IL · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Chicago, IL · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Chicago, IL · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Arlington Heights, IL · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Arlington Heights, IL · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Arlington Heights, IL · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Arlington Heights, IL · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Chicago, IL · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Chicago, IL · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Arlington Heights, IL · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Arlington Heights, IL · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Internship Computer System Validation Csv information
What is an internship in computer system validation (CSV)?
An Internship in Computer System Validation (CSV) is a temporary position, typically for students or recent graduates, that provides hands-on experience in ensuring that computer systems used in regulated industries (like pharmaceuticals or healthcare) meet required standards and regulations. Interns assist with validating software and hardware, documenting processes, and ensuring compliance with industry guidelines such as FDA 21 CFR Part 11 or EU Annex 11. This role helps interns understand the lifecycle of computer systems in a regulated environment and prepares them for careers in quality assurance, compliance, or IT within highly regulated sectors.
What is the difference between Internship Computer System Validation Csv vs Computer System Validation Specialist?
| Aspect | Internship Computer System Validation Csv | Computer System Validation Specialist |
|---|---|---|
| Credentials | Typically pursuing or recent graduate, basic understanding of validation | Relevant certifications (e.g., GAMP, ISPE), experience preferred |
| Work Environment | Internship setting, supervised, entry-level tasks | Full-time role, independent responsibilities in regulated industries |
| Industry Usage | Used in pharmaceutical, biotech, and medical device companies for training | Used for maintaining compliance, validating systems in regulated environments |
In summary, the Internship Computer System Validation Csv is an entry-level position focused on learning and supporting validation tasks, while the Computer System Validation Specialist is a more experienced role responsible for ensuring system compliance and validation in regulated industries.
What are the key skills and qualifications needed for an internship in computer system validation (CSV)?
To thrive as an Internship Computer System Validation CSV specialist, you need foundational knowledge in computer science, life sciences, or engineering, along with an understanding of regulatory standards like GxP or FDA 21 CFR Part 11. Familiarity with validation documentation, software testing tools, and quality management systems is typically required. Attention to detail, analytical thinking, and effective communication are crucial soft skills for interpreting requirements and collaborating with cross-functional teams. These skills ensure compliance, data integrity, and the successful validation of computerized systems in regulated environments.
What are the typical responsibilities of an intern in computer system validation (CSV)?
As a Computer System Validation (CSV) intern, you can expect to assist with tasks such as reviewing and drafting validation documentation, executing test scripts, and collecting evidence to ensure compliance with regulatory requirements. You may also support the maintenance of validation records and participate in team meetings to discuss project progress or findings. These responsibilities are crucial in ensuring that computer systems used in regulated industries, like pharmaceuticals or healthcare, function as intended and meet quality standards. Working closely with senior validation specialists, you'll gain hands-on experience with industry guidelines and learn how cross-functional teams collaborate to achieve compliance.
What are the most commonly searched types of Computer System Validation Csv jobs in Illinois? The most popular types of Computer System Validation Csv jobs in Illinois are:
What are popular job titles related to Internship Computer System Validation Csv jobs in Illinois? For Internship Computer System Validation Csv jobs in Illinois, the most frequently searched job titles are:
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Job description
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
PLEASE NOTE: This is a hybrid role requiring three days a week in the office. Candidates can be based out of our Chicago (Headquarters), New York, or Redwood City locations.
As a Senior Quality Engineer, you will:
Responsibilities:
Qualifications
Chicago Pay Range: $90,000-$130,00
NYC/SF Pay Range: $100,000-$150,000
The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
PLEASE NOTE: This is a hybrid role requiring three days a week in the office. Candidates can be based out of our Chicago (Headquarters), New York, or Redwood City locations.
As a Senior Quality Engineer, you will:
- Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s).
- Lead risk assessments to determine testing strategies.
- Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA guidance, other applicable regulatory requirements, as well as best practices in the software industry.
- Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements.
Responsibilities:
- Support regulatory compliance of the host system operating with Tempus Medical Device(s).
- Develop and maintain CSV policies, procedures, templates and work instructions.
- Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities.
- Perform validation, re-validation and change controls of various AI, SaaS, and Tempus in-house developed software.
- Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports.
- Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution.
- Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement.
- Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits.
- Provide CSV guidance, coaching, mentorship, and training to test engineers within the team.
Qualifications
- BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
- 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)
- 3+ years experience in Computer System Validation (CSV).
- Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).
- Knowledge of quality system principles, practices, and standards for the life science industry.
- Ability to deliver quality outputs without directions or under minimal supervision.
Chicago Pay Range: $90,000-$130,00
NYC/SF Pay Range: $100,000-$150,000
The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.