The Impact You Will Make The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP computer systems used in pharmaceutical manufacturing environments are validated ...
The Impact You Will Make The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP computer systems used in pharmaceutical manufacturing environments are validated ...
The Impact You Will Make The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP computer systems used in pharmaceutical manufacturing environments are validated ...
The Impact You Will Make The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP computer systems used in pharmaceutical manufacturing environments are validated ...
The Impact You Will Make The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP computer systems used in pharmaceutical manufacturing environments are validated ...
The Impact You Will Make The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP computer systems used in pharmaceutical manufacturing environments are validated ...
The Impact You Will Make The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP computer systems used in pharmaceutical manufacturing environments are validated ...
The Impact You Will Make The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP computer systems used in pharmaceutical manufacturing environments are validated ...
The Impact You Will Make The Computer System Validation (CSV) Specialist is responsible for ... Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our ...
The Impact You Will Make The Computer System Validation (CSV) Specialist is responsible for ... Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our ...
WORK FROM HOME
Brookline, MO · On-site +1
$300 - $500/wk
We use data driven systems and cutting edge lead generation that gets you connected with interested ... Must have a computer and phone to service the clients. * This is all online so internet connection ...
WORK FROM HOME
Brookline, MO · On-site +1
$300 - $500/wk
We use data driven systems and cutting edge lead generation that gets you connected with interested ... Must have a computer and phone to service the clients. * This is all online so internet connection ...
$12.50/hr
... system. The questions typically involve a variety of business, health, political and economic ... A relatively up-to-date home computer * A strong Ethernet/broadband internet connection at home * A ...
$12.50/hr
... system. The questions typically involve a variety of business, health, political and economic ... A relatively up-to-date home computer * A strong Ethernet/broadband internet connection at home * A ...
$12.50/hr
... system. The questions typically involve a variety of business, health, political and economic ... A relatively up-to-date home computer * A strong Ethernet/broadband internet connection at home * A ...
$12.50/hr
... system. The questions typically involve a variety of business, health, political and economic ... A relatively up-to-date home computer * A strong Ethernet/broadband internet connection at home * A ...
$12.50/hr
... system. The questions typically involve a variety of business, health, political and economic ... A relatively up-to-date home computer * A strong Ethernet/broadband internet connection at home * A ...
$12.50/hr
... system. The questions typically involve a variety of business, health, political and economic ... A relatively up-to-date home computer * A strong Ethernet/broadband internet connection at home * A ...
Our reviewers visit physicians' offices to retrieve and review specific documents from medical ... home computer, and printer Additional Information
Our reviewers visit physicians' offices to retrieve and review specific documents from medical ... home computer, and printer Additional Information
Our reviewers visit physicians' offices to retrieve and review specific documents from medical ... home computer, and printer
Our reviewers visit physicians' offices to retrieve and review specific documents from medical ... home computer, and printer
Work-from-Home Client Relations
Columbia, MO · On-site +1
Join Our Team - Work From Anywhere Are you a motivated, experienced sales professional ready to ... Leverage CRM systems and digital tools to improve workflows and productivity Required Skills ...
Work-from-Home Client Relations
Columbia, MO · On-site +1
Join Our Team - Work From Anywhere Are you a motivated, experienced sales professional ready to ... Leverage CRM systems and digital tools to improve workflows and productivity Required Skills ...
HOME BASED INSURANCE SALES/WORK FROM HOME
Grandview, MO · On-site +1
$300 - $500/wk
We use data driven systems and cutting edge lead generation that gets you connected with interested ... Must have a computer and phone to service the clients. * This is all online so internet connection ...
HOME BASED INSURANCE SALES/WORK FROM HOME
Grandview, MO · On-site +1
$300 - $500/wk
We use data driven systems and cutting edge lead generation that gets you connected with interested ... Must have a computer and phone to service the clients. * This is all online so internet connection ...
WORK FROM HOME/HOME BASED INSURANCE AGENT
Columbia, MO · On-site +1
$300 - $500/wk
We use data driven systems and cutting edge lead generation that gets you connected with interested ... Must have a computer and phone to service the clients. * This is all online so internet connection ...
WORK FROM HOME/HOME BASED INSURANCE AGENT
Columbia, MO · On-site +1
$300 - $500/wk
We use data driven systems and cutting edge lead generation that gets you connected with interested ... Must have a computer and phone to service the clients. * This is all online so internet connection ...
HOME BASED INSURANCE SALES/WORK FROM HOME
Independence, MO · On-site +1
$300 - $500/wk
We use data driven systems and cutting edge lead generation that gets you connected with interested ... Must have a computer and phone to service the clients. * This is all online so internet connection ...
HOME BASED INSURANCE SALES/WORK FROM HOME
Independence, MO · On-site +1
$300 - $500/wk
We use data driven systems and cutting edge lead generation that gets you connected with interested ... Must have a computer and phone to service the clients. * This is all online so internet connection ...
⌨ Sales Agent - Work from Home
Springfield, MO · On-site +1
⌨ Sales Agent - Work from Home Location: Remote Position/Work from Home Job Type: Full-Time ... Basic computer skills for CRM and client management Locations Springfield, MO, 65807 Remote status ...
⌨ Sales Agent - Work from Home
Springfield, MO · On-site +1
⌨ Sales Agent - Work from Home Location: Remote Position/Work from Home Job Type: Full-Time ... Basic computer skills for CRM and client management Locations Springfield, MO, 65807 Remote status ...
LIFE INSURANCE AGENT / WORK FROM HOME
Saint Louis, MO · On-site +1
$300 - $500/wk
We use data driven systems and cutting edge lead generation that gets you connected with interested ... Must have a computer and phone to service the clients. * This is all online so internet connection ...
LIFE INSURANCE AGENT / WORK FROM HOME
Saint Louis, MO · On-site +1
$300 - $500/wk
We use data driven systems and cutting edge lead generation that gets you connected with interested ... Must have a computer and phone to service the clients. * This is all online so internet connection ...
⌨ Sales Agent - Work from Home
Springfield, MO · On-site +1
⌨ Sales Agent - Work from Home Location: Remote Position/Work from Home Job Type: Full-Time ... Basic computer skills for CRM and client management Locations Springfield, MO, 65807 Remote status ...
⌨ Sales Agent - Work from Home
Springfield, MO · On-site +1
⌨ Sales Agent - Work from Home Location: Remote Position/Work from Home Job Type: Full-Time ... Basic computer skills for CRM and client management Locations Springfield, MO, 65807 Remote status ...
⌨ Sales Agent - Work from Home
Springfield, MO · On-site +1
⌨ Sales Agent - Work from Home Location: Remote Position/Work from Home Job Type: Full-Time ... Basic computer skills for CRM and client management Locations Springfield, MO, 65807 Remote status ...
⌨ Sales Agent - Work from Home
Springfield, MO · On-site +1
⌨ Sales Agent - Work from Home Location: Remote Position/Work from Home Job Type: Full-Time ... Basic computer skills for CRM and client management Locations Springfield, MO, 65807 Remote status ...
AgencyHub.com - Work From Home
Blue Springs, MO · Remote
$15K/mo
This is a fantastic opportunity to work from the comfort of your own home, anywhere in the USA ... If you're fast on your feet (and even faster on a computer), this might just be the perfect fit for ...
AgencyHub.com - Work From Home
Blue Springs, MO · Remote
$15K/mo
This is a fantastic opportunity to work from the comfort of your own home, anywhere in the USA ... If you're fast on your feet (and even faster on a computer), this might just be the perfect fit for ...
From Home Computer System Validation information
What is the difference between From Home Computer System Validation vs From Home Quality Assurance Specialist?
| Aspect | From Home Computer System Validation | From Home Quality Assurance Specialist |
|---|---|---|
| Certifications | GxP validation, 21 CFR Part 11 | ISO 9001, QA certifications |
| Work Environment | Primarily remote, focused on system testing and validation | Remote or onsite, focused on process audits and compliance |
| Industry Usage | Pharmaceutical, biotech, healthcare | Manufacturing, software, healthcare |
| Job Focus | Ensuring computer systems meet regulatory standards | Ensuring overall quality processes and compliance |
From Home Computer System Validation primarily involves verifying that computer systems meet regulatory standards, especially in healthcare and biotech industries. In contrast, From Home Quality Assurance Specialist focuses on broader quality processes and compliance across various industries. Both roles may be remote and require similar certifications, but their core responsibilities differ in scope and focus.

Kindeva rating
6.8
Based on 6 frontline employees who took The Breakroom Quiz
Job description
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP computer systems used in pharmaceutical manufacturing environments are validated, maintained, and compliant with applicable regulatory requirements including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
This role supports the full lifecycle of computerized systems including implementation, qualification, maintenance, periodic review, and retirement, ensuring data integrity, system reliability, and inspection readiness across multiple sites or facilities.
Responsibilities
- Validation Lifecycle Execution
- Lead and/or support validation activities for GxP computerized systems including MES, SCADA/PLC, LIMS, EM systems, and serialization/packaging systems
- Author and execute validation documentation: URS, FS/DS, Risk Assessments, IQ/OQ/PQ, Traceability Matrices, Periodic Reviews / Audit Trail Reviews
- Ensure validation deliverables meet internal SOPs and regulatory expectation
- Regulatory Compliance & Data Integrity
- Ensure compliance with 21 CFR Part 11, EU Annex 11, and ALCOA+ principles
- Perform periodic reviews of validated systems
- Support FDA, EMA, and internal audits/inspections
- Assess and remediate data integrity risks
- Change Control & Lifecycle Management
- Support system changes through formal change control processes
- Evaluate impact of updates, patches, and configuration changes
- Ensure appropriate re-validation activities
- Maintain systems in a validated state
- Risk-Based Validation Strategy
- Apply GAMP 5 risk-based validation approach
- Classify systems based on complexity and GxP impact
- Lead risk assessments (FMEA, system risk ranking)
- Cross-Functional Collaboration
- Partner with IT, QA, Manufacturing, MS&T, and Engineering
- Provide CSV guidance during system implementation and facility startup
- Support digital transformation initiatives
- Documentation & Inspection Readiness
- Maintain GMP-compliant validation documentation
- Ensure audit readiness and traceability
- Support responses to audit findings and regulatory observations
- Continuous Improvement
- Improve validation processes and templates
- Support implementation of electronic validation systems (e.g., Kneat, Veeva)
- Drive standardization across sites
Qualifications
- Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or related field
- Minimum of 5 years in Computer System Validation in GMP-regulated pharmaceutical or biotech environments
- Experience with manufacturing and laboratory systems validation
- Hands-on experience with Part 11 / Annex 11 compliance
- Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+
- Familiarity with MES, ERP, LIMS, SCADA/PLC systems
- Understanding of system architecture, interfaces, backup, disaster recovery, and cybersecurity
- Experience in aseptic/sterile injectable manufacturing preferred
- Multi-site validation program experience preferred
- Familiarity with serialization, AVI systems, and cold storage monitoring preferred
- Experience with Kneat, ValGenesis, or Veeva is desirable
- Experience with facility startup and commissioning
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