CSV Engineer
Karwell TechnologiesNewark, DE
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.1
Reclaim your time by letting our AI handle the grunt work of job searching.
We continuously scan millions of openings to find your top matches.
Overview
Remote
On-site
Job Description
Job Description: We are looking for a Computer System Validation (CSV) Engineer to support our client in Newark, DE. In this role, you will be responsible for ensuring that computerised systems used in regulated environments are validated and compliant with industry standards. You will work closely with IT, Quality, and business teams to support validation activities and maintain system compliance throughout its lifecycle.
Roles & Responsibilities:
- Lead and support CSV activities for GxP systems, including validation planning, execution, and reporting.
- Develop and review validation deliverables such as Validation Plans, URS, FS/DS, IQ, OQ, PQ protocols, and summary reports.
- Ensure compliance with FDA 21 CFR Part 11, 21 CFR Part 820, and GAMP 5 guidelines.
- Perform risk assessments to determine validation scope and testing requirements.
- Support system implementation, upgrades, and changes through change control processes.
- Collaborate with cross-functional teams (IT, QA, Validation, and business users).
- Maintain and review validation documentation to ensure accuracy and completeness.
- Participate in audit readiness activities and support regulatory inspections.
- Identify and resolve validation deviations, discrepancies, and non-conformances.
- Ensure proper data integrity and security compliance across systems.
- Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field.
- Experience in Computer System Validation in a GxP environment.
- Strong understanding of CSV lifecycle and validation documentation.
- Hands-on experience with GAMP 5, 21 CFR Part 11 compliance.
- Familiarity with a risk-based validation approach.
- Strong communication and documentation skills.
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
FAQs About CSV Engineer Jobs at Karwell Technologies
What is the work location for this position at Karwell Technologies?
This job at Karwell Technologies is located in Newark, DE, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Karwell Technologies?
Employer has not shared pay details for this role.
What employment applies to this position at Karwell Technologies?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Karwell Technologies?
You can apply for this role at Karwell Technologies either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.