Description The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications, enterprise databases, data ...
Description The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications, enterprise databases, data ...
CSV Engineer
Raleigh, NC · On-site
Job Type Full-time Description The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications ...
CSV Engineer
Raleigh, NC · On-site
Job Type Full-time Description The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications ...
CSV Engineer
Raleigh, NC · On-site
The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications, enterprise databases, data platforms ...
Quick apply
CSV Engineer
Raleigh, NC · On-site
The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications, enterprise databases, data platforms ...
Position Summary The CSV/CQV Engineer will support the commissioning, qualification, and validation of process equipment, utilities, facilities, and PAT systems. This role is responsible for all ...
Position Summary The CSV/CQV Engineer will support the commissioning, qualification, and validation of process equipment, utilities, facilities, and PAT systems. This role is responsible for all ...
CSV Specialist II
Durham, NC · On-site
Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all systems are in a qualified state suitable for the intended use.
CSV Specialist II
Durham, NC · On-site
Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all systems are in a qualified state suitable for the intended use.
Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all systems are in a qualified state suitable for the intended use.
Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all systems are in a qualified state suitable for the intended use.
6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2
Durham, NC · On-site
$65K - $90K/yr
General CSV Skills * Familiarity with global standards for computerized systems and data integrity. * Ability to classify systems as "simple" or "complex" using risk‑based criteria to right‑size ...
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6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2
Durham, NC · On-site
$65K - $90K/yr
General CSV Skills * Familiarity with global standards for computerized systems and data integrity. * Ability to classify systems as "simple" or "complex" using risk‑based criteria to right‑size ...
6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2
Durham, NC · On-site
$65K - $90K/yr
General CSV Skills * Familiarity with global standards for computerized systems and data integrity. * Ability to classify systems as "simple" or "complex" using risk-based criteria to right-size ...
6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2
Durham, NC · On-site
$65K - $90K/yr
General CSV Skills * Familiarity with global standards for computerized systems and data integrity. * Ability to classify systems as "simple" or "complex" using risk-based criteria to right-size ...
Computer Systems Validation (Software Quality Assurance - CSV) Durham, NC Long Term Contract rate to commensurate with experience Our client is a world leader in the exciting and dynamic fields of ...
Computer Systems Validation (Software Quality Assurance - CSV) Durham, NC Long Term Contract rate to commensurate with experience Our client is a world leader in the exciting and dynamic fields of ...
... CSV on risk‑based validation (GAMP 5, CSA) and audit readiness • Define and enforce standards, templates, libraries, and master data structures in partnership with Master Data teams • Deploy ...
... CSV on risk‑based validation (GAMP 5, CSA) and audit readiness • Define and enforce standards, templates, libraries, and master data structures in partnership with Master Data teams • Deploy ...
We are seeking a flexible and adaptable Validation Engineer (CSV Lead) to represent our team in North Carolina. In this role, you will be responsible for the validation strategy and SDLC ...
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We are seeking a flexible and adaptable Validation Engineer (CSV Lead) to represent our team in North Carolina. In this role, you will be responsible for the validation strategy and SDLC ...
Division Quality Engineer I
$69K - $89K/yr
Author, review, execute, and approve CSV lifecycle documentation, including: * Ensure computerized systems remain in a validated state through effective management of: * Participate in system risk ...
Division Quality Engineer I
$69K - $89K/yr
Author, review, execute, and approve CSV lifecycle documentation, including: * Ensure computerized systems remain in a validated state through effective management of: * Participate in system risk ...
Ensure cGxP, data integrity (ALCOA+), and data security across integrations; partner with QA/CSV on risk-based validation (GAMP 5, CSA) and audit readiness * Define and enforce standards, templates ...
Ensure cGxP, data integrity (ALCOA+), and data security across integrations; partner with QA/CSV on risk-based validation (GAMP 5, CSA) and audit readiness * Define and enforce standards, templates ...
Participate as a CSV SME in audits and inspections and provide needed documentation to demonstrate validated state and release to use * Collaborate with cross-functional teams to ensure that all ...
Participate as a CSV SME in audits and inspections and provide needed documentation to demonstrate validated state and release to use * Collaborate with cross-functional teams to ensure that all ...
Participate as a CSV SME in audits and inspections and provide needed documentation to demonstrate validated state and release to use * Collaborate with cross-functional teams to ensure that all ...
Participate as a CSV SME in audits and inspections and provide needed documentation to demonstrate validated state and release to use * Collaborate with cross-functional teams to ensure that all ...
Ensure cGxP, data integrity (ALCOA+), and data security across integrations; partner with QA/CSV on riskbased validation (GAMP 5, CSA) and audit readiness * Define and enforce standards, templates ...
Ensure cGxP, data integrity (ALCOA+), and data security across integrations; partner with QA/CSV on riskbased validation (GAMP 5, CSA) and audit readiness * Define and enforce standards, templates ...
Ensure cGxP, data integrity (ALCOA+), and data security across integrations; partner with QA/CSV on riskbased validation (GAMP 5, CSA) and audit readiness * Define and enforce standards, templates ...
Ensure cGxP, data integrity (ALCOA+), and data security across integrations; partner with QA/CSV on riskbased validation (GAMP 5, CSA) and audit readiness * Define and enforce standards, templates ...
Participate as a CSV SME in audits and inspections and provide needed documentation to demonstrate validated state and release to use * Collaborate with cross-functional teams to ensure that all ...
Participate as a CSV SME in audits and inspections and provide needed documentation to demonstrate validated state and release to use * Collaborate with cross-functional teams to ensure that all ...
FAT, SAT, CSV, equipment integration, and startup. * Drive process design for new equipment and ensure product design requirements are met. * Execute commissioning and qualification activities for ...
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FAT, SAT, CSV, equipment integration, and startup. * Drive process design for new equipment and ensure product design requirements are met. * Execute commissioning and qualification activities for ...
Equipment Validation Engineer
Raleigh, NC · On-site
This Validation Engineer will work cross-functionally with Manufacturing, Quality, Engineering, and Automation teams to support equipment qualification, system integration, and potential CSV ...
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Equipment Validation Engineer
Raleigh, NC · On-site
This Validation Engineer will work cross-functionally with Manufacturing, Quality, Engineering, and Automation teams to support equipment qualification, system integration, and potential CSV ...
Csv information
What is the difference between Csv vs Data Analyst?
| Aspect | Csv | Data Analyst |
|---|---|---|
| Required Credentials | Basic knowledge of data formats, often no formal degree required | Bachelor's degree in statistics, data science, or related field |
| Work Environment | Data entry, data cleaning, often in office or remote settings | Analyzing data, creating reports, collaborating with teams |
| Industry Usage | Used across industries for data management | Applied in finance, marketing, healthcare, and more |
| Search & Comparison Intent | Understanding data formats and tools | Analyzing data to inform business decisions |
While Csv refers to a data format used for storing and exchanging data, a Data Analyst is a professional who interprets and analyzes data to help organizations make informed decisions. Csv is a tool or format that Data Analysts often work with, but they are distinct concepts: Csv is a file type, whereas Data Analyst is a job role.
What are the key skills and qualifications needed to thrive as a Civil Engineer, and why are they important?
What are some common challenges faced by Customer Service Representatives (CSRs) and how can they be managed effectively?
What are CSV files?
- Pharmaceutical Validation
- Remote Validation
- Computer System Validation
- Csv Validation Engineer
- Verification And Validation Engineer
- Computer System Validation Csv Pharmaceutical
- Validation Engineer Iq Oq Pq
- Computer System Validation Csv
- Medical Device Validation Engineer
- Entry Level Pharmaceutical Validation

Other
Medical, Dental, Vision, Retirement, PTO
Posted 19 days ago
Job description
Description
The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications, enterprise databases, data platforms, and business intelligence solutions used within regulated GxP environments. This role partners with IT, Software Development, Data Engineering, Manufacturing, Quality, and business stakeholders to ensure that custom software applications, databases, reporting platforms, and system integrations are designed, validated, and maintained in compliance with regulatory requirements and industry best practices.
This position requires an experienced validation professional who is equally comfortable discussing validation strategy with Quality, reviewing software architecture with developers, validating SQL queries and database structures, and ensuring the integrity of data flowing between enterprise systems. The successful candidate will lead validation efforts across the full software development lifecycle, with particular emphasis on custom applications, relational databases, enterprise data warehouses/lakehouses, data pipelines, APIs, and business intelligence platforms that support manufacturing, laboratory, and business operations.
Requirements
Lead Computer System Validation (CSV) activities for custom-developed applications, enterprise databases, data platforms, dashboards, and other GxP computerized systems.
Partner with software developers, data engineers, IT, Quality, and business stakeholders to define validation strategies and ensure compliance throughout the software development lifecycle.
Author and execute validation deliverables including Validation Plans, URS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, test scripts, and Validation Summary Reports.
Validate custom applications, Power BI dashboards, enterprise databases, and cloud-based data platforms while performing SQL-based testing, data reconciliation, and verification activities.
Validate system integrations, data pipelines, APIs, and interfaces between enterprise applications including LIMS, MES, ERP, PI Historian, and related GxP systems.
Verify data integrity, security, audit trail, and electronic records controls to ensure compliance with GxP and regulatory requirements.
Support audit readiness by maintaining compliant validation documentation and providing technical leadership on CSV, CSA, database validation, and data integrity best practices.
Experience & Skills
Bachelor's degree in Engineering, Computer Science, Information Systems, Software Engineering, Life Sciences, or a related technical discipline.
7+ years of Computer System Validation (CSV) experience supporting custom software applications, enterprise databases, data platforms, and computerized systems within pharmaceutical, biotechnology, medical device, or other regulated industries.
Demonstrated experience validating custom-developed applications, database-driven systems, enterprise integrations, and business intelligence platforms such as Power BI.
Strong knowledge of relational databases, SQL, data architecture, data validation methodologies, and cloud-based data platforms such as Azure Data Lake, Databricks, Synapse, OneLake, SQL Server, Oracle, PostgreSQL, or similar technologies.
Thorough understanding of GAMP 5, Computer Software Assurance (CSA), 21 CFR Part 11, EU Annex 11, ALCOA+ Data Integrity principles, and cGMP regulations.
Experience leading validation efforts across the software development lifecycle, including requirements, risk assessments, testing, documentation, and audit readiness.
Excellent analytical, troubleshooting, communication, and cross-functional collaboration skills.
Benefits & Compensation
Industry competitive wage as a full-time employee
Flexible Paid Time Off
Bonus plans
Medical, Dental and Vision Insurance with low employee cost
Employer paid long term and short-term disability
401k plan with employer contributions
About Alliance Biotech Solutions
Alliance Biotech Solutions (ABS) is a premier consulting firm specializing in biopharmaceutical engineering and validation services. As industry leaders in Commissioning, Qualification, and Validation (CQV), we provide crucial services to the biotech and pharmaceutical sectors while maintaining our philosophy that employees are our #1 priority. Our success is built on the foundation of empowering our team members' growth and development, recognizing that our employees are the cornerstone of our clients' success.
Alliance Biotech Solutions is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.
Alliance Biotech Solutions does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Alliance Biotech Solutions, and Alliance Biotech Solutions will not be obligated to pay a placement fee.
All persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.