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Csv Manager Jobs (NOW HIRING)

The CSV Specialist will be responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full validation lifecycle, ensuring compliance with FDA ...

The CSV Specialist will be responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full validation lifecycle, ensuring compliance with FDA ...

IT CSV Engineer

Redmond, WA · On-site

$115K - $135K/yr

Senior Manager/Group Leader, CSV About Us: At Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status ...

... • Managing change controls including creation, execution, and closure • Supporting data ... Required : • Strong CSV (Computer System Validation) experience • Hands-on experience with ...

IT CSV Engineer

Redmond, WA · On-site

$115K - $135K/yr

Senior Manager/Group Leader, CSV About Us: At Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status ...

CSV Specialist

Lexington, MA · On-site

$45 - $52/hr

The role partners closely with Quality Systems, QC, Project Management, and technical SMEs to ... Minimum 5 years in pharmaceutical or biopharmaceutical CSV. * Strong understanding of cGxP, GAMP5 ...

Sr. CSV Specialist

Raritan, NJ · On-site

$84K - $116K/yr

Manages multiple and complex CSV projects in accordance with CQV, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks. * Supports and/or ...

CSV Engineer

Costa Mesa, CA · On-site

$55 - $60/hr

CSV Engineer Costa Mesa, CA or Seattle, WA(On-site) Visa: USC, GC & H4 EAD Key Responsibilities ... Ability to manage multiple projects under tight deadlines.

Manages multiple and complex CSV projects in accordance with CQV, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks. * Supports and/or ...

$84K - $116K/yr

Manages multiple and complex CSV projects in accordance with CQV, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.Supports and/or owns ...

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Csv Manager information

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$29K

$104.6K

$118K

How much do csv manager jobs pay per year?

As of Aug 3, 2026, the average yearly pay for csv manager in the United States is $104,575.00, according to ZipRecruiter salary data. Most workers in this role earn between $114,000.00 and $116,500.00 per year, depending on experience, location, and employer.

What are some common challenges faced by a CSV Manager in maintaining regulatory compliance across multiple projects?

A CSV (Computer System Validation) Manager often manages several projects simultaneously, each with unique regulatory requirements. One major challenge is ensuring that all validation documentation remains current and audit-ready, despite frequent software updates or process changes. Additionally, coordinating with cross-functional teams such as IT, Quality Assurance, and Operations can be demanding, as priorities and timelines may differ. Staying updated with evolving industry regulations and effectively training team members are also essential to maintaining consistent compliance.

What is a CSV Manager?

A CSV Manager is a software tool or professional responsible for handling, organizing, and processing CSV (Comma-Separated Values) files. These files are commonly used for storing and exchanging data in a simple text format, making them popular for data imports and exports in various applications. A CSV Manager ensures that the data within these files is correctly formatted, validated, and sometimes transformed for compatibility with databases or other systems. They may also automate workflows involving large amounts of CSV data to improve efficiency and accuracy.

What is the difference between Csv Manager vs Data Analyst?

AspectCsv ManagerData Analyst
Required CredentialsExperience with CSV data management, basic database skillsDegree in statistics, data science, or related field; proficiency in data analysis tools
Work EnvironmentData management teams, IT departmentsBusiness analysis teams, research departments
Employer & Industry UsageUsed in industries handling large CSV datasets, such as logistics and financeUsed across industries for interpreting data, reporting, and decision-making

The Csv Manager primarily focuses on managing and organizing CSV data files, ensuring data integrity and accessibility. In contrast, a Data Analyst interprets data, creates reports, and provides insights. While both roles work with data, Csv Managers specialize in data handling, whereas Data Analysts focus on analysis and interpretation.

What are the key skills and qualifications needed to thrive as a CSV Manager, and why are they important?

To thrive as a CSV (Computer System Validation) Manager, you need a strong background in GxP regulations, validation methodologies, and a degree in life sciences, engineering, or a related field. Familiarity with validation lifecycle documentation, risk assessment tools, and regulatory standards like FDA 21 CFR Part 11 is typically required. Outstanding project management, attention to detail, and strong communication skills make a CSV Manager stand out in ensuring compliance and leading cross-functional teams. These competencies are crucial for ensuring validated systems meet regulatory requirements and support business operations in highly regulated industries.
More about Csv Manager jobs
What cities are hiring for Csv Manager jobs? Cities with the most Csv Manager job openings:
What states have the most Csv Manager jobs? States with the most job openings for Csv Manager jobs include:
Infographic showing various Csv Manager job openings in the United States as of July 2026, with employment types broken down into 2% As Needed, 80% Full Time, 2% Part Time, 1% Temporary, 10% Contract, and 5% Summer. Highlights an 83% Physical, 3% Hybrid, and 14% Remote job distribution, with an average salary of $104,575 per year, or $50.3 per hour.

Business Systems Analyst II

American Regent, Inc.

New Albany, OH • On-site

Full-time

Re-posted 17 days ago


American Regent rating

7.2

Company rating: 7.2 out of 10

Based on 12 frontline employees who took The Breakroom Quiz

69th of 86 rated pharmaceutical


Job description

Nature and Scope
The Business Systems Analyst II (BSA-II) serves as a liaison between business stakeholders and information technology, translating business needs into system requirements and ensuring technology solutions support operational, regulatory, and quality objectives. This role supports the implementation, validation, and lifecycle management of GxP-regulated computerized systems within a regulated pharmaceutical environment. The BSA-II will ensure adherence to industry standards and regulations pertaining to CSV, data integrity as well as all internal quality system requirements. The BSA-II independently executes moderately complex assignments within established system governance and validation frameworks.
The BSA-II will report directly to the CSV Manager and work closely with members of the CSV team, IT, QA, Business and System Owners.
Essential Duties and Responsibilities
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
  • Obtain, analyze, document, and validate business, functional, and system requirements for new and existing applications supporting GxP business processes.
  • Translate business and regulatory requirements into system-based solutions in collaboration with IT, Quality, system owners, the business and vendors.
  • Assess the impact of system changes on validated state, business processes, and data integrity.
  • Support CSV activities across the system lifecycle, including implementation, configuration changes, upgrades, and retirement.
  • Author, review, approve and maintain CSV deliverables including User Requirements Specifications (URS), Risk assessments (e.g., system impact, data integrity, patient safety), Functional Specification (FS), Configuration Specifications (CS), Security Specifications (SS), Design Specifications (DS), Qualification Protocols (IQ/OQ/PQ), Traceability matrices, Validation plans and summary documentation (as applicable).
  • Ensure system requirements are testable, traceable, and inspection-ready.
  • Ensure system changes are appropriately assessed for risk and documented according to change management procedures.
  • Identify and communicate data integrity, compliance, or validation risks associated with system changes.
  • Contribute to audit and inspection readiness activities by ensuring documentation is complete, current, and accurate.
  • Support responses to audit/inspection requests and observations related to computerized systems, when applicable.
  • Support system implementations including validation execution and support testing activities (e.g., IQ/OQ/PQ/UAT, protocol review, defect assessment), enhancements, periodic reviews, and retirement activities.
  • Participate in development and maintenance of SOPs, work instructions, and validated system documentation.
  • Partner with Quality, Manufacturing, Supply Chain, Regulatory, IT, and other stakeholders to align system functionality with regulated business needs and to support continuous improvement while maintaining compliance.
  • Facilitate workshops, risk discussions, and validation reviews to obtain requirements.
  • Communicate effectively with both technical and non-technical stakeholders using clear, structured communication and documentation.
  • Consistently perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
  • Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
  • Bachelor's degree in Information Systems, Engineering, Business, Computer Science, or STEM related discipline (or equivalent experience).
  • 3-6 years of experience as a Business Systems Analyst, Business Analyst, Computer System Validation or similar role.
  • Hands-on experience supporting administrative activities for validated or GxP-regulated computerized systems.
  • Experience working within SDLC and CSV frameworks in a pharmaceutical, biotech, or other regulated environment.
  • Strong requirements elicitation and documentation skills in regulated environments.
  • Working knowledge of CSV concepts, including requirements, risk management, and traceability.
  • Strong understanding of FDA, EU, GAMP, ICH and data integrity expectations for computerized systems.
  • Ability to apply risk-based thinking to validation and system changes.
  • Strong analytical, organizational, and problem-solving skills.
  • Clear written and verbal communication suitable for audits and inspections.
  • Ability to manage multiple priorities while maintaining compliance rigor.
  • Experience with FDA Computer Software Assurance (CSA) and Computer Software Validation (CSV) principles.
  • Experience supporting validated COTS platforms (e.g., LIMS, QMS, ERP, TrackWise, Veeva, SAP, MES, Empower, OpenLab, Chromeleon).
  • Experience with change control, periodic reviews, and system retirement activities.
  • Experience using validation lifecycle management tools (e.g., Res_Q, ValGenesis, KNEAT).

Physical Environment and Requirements
  • Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
  • FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
  • Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
  • Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Alert: We're aware of individuals impersonating our staff to target job seekers. Please note:
• All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
• Our recruiting process includes multiple in person and/or video interviews and assessments.
• If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.
• We never request payment, bank information, or personal financial details during our offer process.
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