This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. * Leads the effort to manage, and/or maintains ...
This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. * Leads the effort to manage, and/or maintains ...
Computer System Validation (CSV): Drive the end-to-end GAMP 5 validation lifecycle for both internal software and cloud-based platforms. Take full ownership of authoring, executing, and finalizing ...
Computer System Validation (CSV): Drive the end-to-end GAMP 5 validation lifecycle for both internal software and cloud-based platforms. Take full ownership of authoring, executing, and finalizing ...
Computer System Validation (CSV): Drive the end-to-end GAMP 5 validation lifecycle for both internal software and cloud-based platforms. Take full ownership of authoring, executing, and finalizing ...
Computer System Validation (CSV): Drive the end-to-end GAMP 5 validation lifecycle for both internal software and cloud-based platforms. Take full ownership of authoring, executing, and finalizing ...
Define and operationalize STAAR Surgical's Computer Software Assurance (CSA) and Computer System Validation (CSV) strategy. Drive transition from traditional documentation-heavy validation models ...
Define and operationalize STAAR Surgical's Computer Software Assurance (CSA) and Computer System Validation (CSV) strategy. Drive transition from traditional documentation-heavy validation models ...
IT Portfolio & Project Manager
Concord, CA · On-site
$108K - $127K/yr
Computer System Validation (CSV) and Regulatory Compliance * Coordinate and support Computer System Validation (CSV) activities, including validation planning, execution, and documentation, in ...
IT Portfolio & Project Manager
Concord, CA · On-site
$108K - $127K/yr
Computer System Validation (CSV) and Regulatory Compliance * Coordinate and support Computer System Validation (CSV) activities, including validation planning, execution, and documentation, in ...
... and Computer System Validation (CSV) strategy. • Drive transition from traditional documentation-heavy validation models toward modern risk-based CSA methodologies. • Establish scalable ...
... and Computer System Validation (CSV) strategy. • Drive transition from traditional documentation-heavy validation models toward modern risk-based CSA methodologies. • Establish scalable ...
Business Application & Systems Administrator
Carpinteria, CA · On-site
$93K - $175K/yr
Write test plans and testing scripts in support of Computer System Validation (CSV) team * Ensure systems meet GxP, FDA 21 CFR Part 11, and other regulatory requirements as required based on ...
Business Application & Systems Administrator
Carpinteria, CA · On-site
$93K - $175K/yr
Write test plans and testing scripts in support of Computer System Validation (CSV) team * Ensure systems meet GxP, FDA 21 CFR Part 11, and other regulatory requirements as required based on ...
Business Application & Systems Administrator
Carpinteria, CA · On-site
$93K - $175K/yr
Write test plans and testing scripts in support of Computer System Validation (CSV) team * Ensure systems meet GxP, FDA 21 CFR Part 11, and other regulatory requirements as required based on ...
Business Application & Systems Administrator
Carpinteria, CA · On-site
$93K - $175K/yr
Write test plans and testing scripts in support of Computer System Validation (CSV) team * Ensure systems meet GxP, FDA 21 CFR Part 11, and other regulatory requirements as required based on ...
Business Analyst
San Francisco, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
San Francisco, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Alameda, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Alameda, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Systems Analyst- PLM/QMS
Carlsbad, CA · On-site
Support Computer System Validation (CSV) activities (IQ/OQ/PQ, evidence, traceability). * Participate in internal and external audits related to Fusion PLM and IT systems. * Support and monitor ...
Systems Analyst- PLM/QMS
Carlsbad, CA · On-site
Support Computer System Validation (CSV) activities (IQ/OQ/PQ, evidence, traceability). * Participate in internal and external audits related to Fusion PLM and IT systems. * Support and monitor ...
Business Analyst
Santa Rosa, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Santa Rosa, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Santa Clara, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Santa Clara, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Sunnyvale, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Sunnyvale, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Fremont, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Fremont, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Sonoma, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Sonoma, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
San Mateo, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
San Mateo, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Hayward, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
Hayward, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
San Jose, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
Business Analyst
San Jose, CA · On-site
Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta * tion.Ensure technology implementations comply with GxP requirements ...
System Validation Engineer
San Jose, CA · On-site
$100K - $113K/yr
Come join R&D Lab in Super Micro Computer. We strive to ensure the product quality and reliability meet the Super Micro 4.0 Standards! We are looking for a System Validation Engineer who is full of ...
System Validation Engineer
San Jose, CA · On-site
$100K - $113K/yr
Come join R&D Lab in Super Micro Computer. We strive to ensure the product quality and reliability meet the Super Micro 4.0 Standards! We are looking for a System Validation Engineer who is full of ...
Computer System Validation Csv information
See California salary details
$29.18 - $33.32
4% of jobs
$33.32 - $37.46
18% of jobs
$38.41 is the 25th percentile. Wages below this are outliers.
$37.46 - $41.60
13% of jobs
$41.60 - $45.74
14% of jobs
The median wage is $46.43 / hr.
$45.74 - $49.88
9% of jobs
$49.88 - $54.03
5% of jobs
$54.03 - $58.17
7% of jobs
$58.17 - $62.31
4% of jobs
$62.42 is the 75th percentile. Wages above this are outliers.
$62.31 - $66.45
9% of jobs
$66.45 - $70.59
12% of jobs
$70.59 - $74.73
4% of jobs
$29
$51
$74
How much do computer system validation csv jobs pay per hour?
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 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 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.

Full-time
Posted 22 days ago
Job description
Should know GxP, Validation and possibly MES
GxP Documentation is must
Seeking a Project Manager with experience in Pharma/ Biotech/ Life Sciences/ Medical Device/ Healthcare or Manufacturing a must (Okay with either industry)
Responsibility:
- This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, and GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11.
- Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system.
- Perform GxP and 21 CFR part 11 assessments and develop validation plan.
- Develop functional risk strategy and perform functional risk assessment.
- Review user business process documents and user requirements specification.
- Review functional, technical and configuration design documents.
- Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols.
- Review the test scripts for the requirements and test scenario coverage.
- Lead overall protocol executions, log and track defects.
- Review the executed test reports for the proper documentation of test results and evidence.
- Review the defects for proper documentation per the checklist.
- Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested.
- Prepare and approve qualification summary report.
- Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.
- Maintain overall project and issue tracker and report routinely.
- Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release.
- Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials.
- Maintain day to day activities status tracker and report routinely.
- Lead the team of validation engineers located in different time zones.
Skills:
- Excellent communication (oral and written) and attention to detail.
- 8+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projects.
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
- Excellent knowledge of GxP regulations, FDA and EMEA (European Medicines Evaluation Agency ) guidelines including 21 CFR Part 11.
- Excellent knowledge of computer system validation and GAMP -5 standards.