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 restricts ...
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 restricts ...
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 restricts ...
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 restricts ...
SUMMARY The Senior Manager, QA Computer System Validation (CSV) is responsible for QA oversight of the validation and compliance of GxP-regulated computerized systems ensuring they are implemented ...
SUMMARY The Senior Manager, QA Computer System Validation (CSV) is responsible for QA oversight of the validation and compliance of GxP-regulated computerized systems ensuring they are implemented ...
CSV Specialist
Gurabo, PR · On-site
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 ...
CSV Specialist
Gurabo, PR · On-site
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 ...
Quick apply
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 ...
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 Engineer
Redwood City, CA · On-site
... • Managing change controls including creation, execution, and closure • Supporting data ... Required : • Strong CSV (Computer System Validation) experience • Hands-on experience with ...
CSV Engineer
Redwood City, CA · On-site
... • 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 ...
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 ...
Hands-on experience with CSV documentation, protocol execution, and validation lifecycle management. * Strong knowledge of GAMP5, 21 CFR Part 11, CSA/CSV methodologies, and Data Integrity principles.
Quick apply
Hands-on experience with CSV documentation, protocol execution, and validation lifecycle management. * Strong knowledge of GAMP5, 21 CFR Part 11, CSA/CSV methodologies, and Data Integrity principles.
Senior CSV & Automation Engineer
Thousand Oaks, CA · On-site
$109K - $143K/yr
I am working on Sr CSV & Automation Engineer position right now. Please send me your updated resume ... Support lifecycle management of computerized systems and automation platforms. * Collaborate with ...
Quick apply
Senior CSV & Automation Engineer
Thousand Oaks, CA · On-site
$109K - $143K/yr
I am working on Sr CSV & Automation Engineer position right now. Please send me your updated resume ... Support lifecycle management of computerized systems and automation platforms. * Collaborate with ...
The CSV Specialist Level 4 provides team leadership and training to assess new and changing ... Strong organizational and time management skills
The CSV Specialist Level 4 provides team leadership and training to assess new and changing ... Strong organizational and time management skills
Manage deviations, investigations, change controls, and validation documentation. * Develop CSV training plans and training matrices. * Monitor CSV milestones, schedules, and project deliverables.
Manage deviations, investigations, change controls, and validation documentation. * Develop CSV training plans and training matrices. * Monitor CSV milestones, schedules, and project deliverables.
Manage change control and deviation management as it pertains to CSV activities * Collaborate with vendors to ensure that third party systems and software meet validation requirements. Conduct vendor ...
Manage change control and deviation management as it pertains to CSV activities * Collaborate with vendors to ensure that third party systems and software meet validation requirements. Conduct vendor ...
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 ...
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 ...
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.
Quick apply
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.
CSV Lead Consultant
Chandler, AZ · Remote
Mandatory Skills CSV, Compliance and Assurance services, LIFE-SCIENCES (GXP FDA CSV IQ/OQ/PQ ... management process. Able to author Validation Plan and compile Validation Summary Report and ...
Quick apply
CSV Lead Consultant
Chandler, AZ · Remote
Mandatory Skills CSV, Compliance and Assurance services, LIFE-SCIENCES (GXP FDA CSV IQ/OQ/PQ ... management process. Able to author Validation Plan and compile Validation Summary Report and ...
Sr. CSV Specialist
Raritan, NJ · On-site
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 ...
Sr. CSV Specialist
Raritan, NJ · On-site
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 Lead - (Delta-V and Rockwell)
Indianapolis, IN · On-site
$98K - $129K/yr
Lead and manage CSV activities for automation systems supporting utilities such as CUP, tank farm, and administrative/laboratory systems. * Develop and implement validation strategies, plans, and ...
Quick apply
CSV Lead - (Delta-V and Rockwell)
Indianapolis, IN · On-site
$98K - $129K/yr
Lead and manage CSV activities for automation systems supporting utilities such as CUP, tank farm, and administrative/laboratory systems. * Develop and implement validation strategies, plans, and ...
$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 ...
$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 ...
Csv Manager information
See salary details
$29K - $37.1K
1% of jobs
$37.1K - $45.2K
5% of jobs
$45.2K - $53.3K
3% of jobs
$53.3K - $61.4K
3% of jobs
$61.4K - $69.5K
3% of jobs
$69.5K - $77.5K
1% of jobs
$77.5K - $85.6K
1% of jobs
$85.6K - $93.7K
1% of jobs
$93.7K - $101.8K
1% of jobs
$101.8K - $109.9K
1% of jobs
$110.3K is the 25th percentile. Wages below this are outliers.
$109.9K - $118K
79% of jobs
$29K
$104.6K
$118K
How much do csv manager jobs pay per year?
What are some common challenges faced by a CSV Manager in maintaining regulatory compliance across multiple projects?
What is a CSV Manager?
What is the difference between Csv Manager vs Data Analyst?
| Aspect | Csv Manager | Data Analyst |
|---|---|---|
| Required Credentials | Experience with CSV data management, basic database skills | Degree in statistics, data science, or related field; proficiency in data analysis tools |
| Work Environment | Data management teams, IT departments | Business analysis teams, research departments |
| Employer & Industry Usage | Used in industries handling large CSV datasets, such as logistics and finance | Used 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?

Full-time
Re-posted 17 days ago
American Regent rating
7.2
Based on 12 frontline employees who took The Breakroom Quiz
69th of 86 rated pharmaceutical
Job description
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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About American Regent
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Shirley, NY, US
Year founded
1910