Candidates should be familiar with COTS systems used for clinical development and quality ... Create and/or review computer system validation test scripts, validation schedules, risk ...
Candidates should be familiar with COTS systems used for clinical development and quality ... Create and/or review computer system validation test scripts, validation schedules, risk ...
The Opportunity The Associate Director, Computer System Validation (CSV) & Quality Compliance provides enterpriselevel leadership, strategic direction, and governance for the validation, lifecycle ...
The Opportunity The Associate Director, Computer System Validation (CSV) & Quality Compliance provides enterpriselevel leadership, strategic direction, and governance for the validation, lifecycle ...
The Opportunity The Associate Director, Computer System Validation (CSV) & Quality Compliance provides enterprise-level leadership, strategic direction, and governance for the validation, lifecycle ...
The Opportunity The Associate Director, Computer System Validation (CSV) & Quality Compliance provides enterprise-level leadership, strategic direction, and governance for the validation, lifecycle ...
Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or ... Understands lifecycle approach as well as risk based approach to validation * Generally familiar ...
Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or ... Understands lifecycle approach as well as risk based approach to validation * Generally familiar ...
System Validation Specialist
Boston, MA · Remote
$55K - $75K/yr
As a System Validation Specialist, you have hands on experience with installing, troubleshooting ... Proven experience working with electrical, mechanical, or computer networking equipment.
Quick apply
System Validation Specialist
Boston, MA · Remote
$55K - $75K/yr
As a System Validation Specialist, you have hands on experience with installing, troubleshooting ... Proven experience working with electrical, mechanical, or computer networking equipment.
At least 2-4 years of Computer System Validation experience in a laboratory environment. Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ ...
At least 2-4 years of Computer System Validation experience in a laboratory environment. Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ ...
Validation Analyst
Norwood, MA · On-site
Drive system validation activities in conjunction with Business, IT, Equipment, Validation and QA ... Provide support to the QC labs for the Benchtop and Enterprise computer systems as system ...
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Validation Analyst
Norwood, MA · On-site
Drive system validation activities in conjunction with Business, IT, Equipment, Validation and QA ... Provide support to the QC labs for the Benchtop and Enterprise computer systems as system ...
Validation Analyst
Norwood, MA · On-site
Drive system validation activities in conjunction with Business, IT, Equipment, Validation and QA ... Provide support to the QC labs for the Benchtop and Enterprise computer systems as system ...
Validation Analyst
Norwood, MA · On-site
Drive system validation activities in conjunction with Business, IT, Equipment, Validation and QA ... Provide support to the QC labs for the Benchtop and Enterprise computer systems as system ...
Validation Analyst
Norwood, MA · On-site
Drive system validation activities in conjunction with Business, IT, Equipment, Validation and QA ... Provide support to the QC labs for the Benchtop and Enterprise computer systems as system ...
Validation Analyst
Norwood, MA · On-site
Drive system validation activities in conjunction with Business, IT, Equipment, Validation and QA ... Provide support to the QC labs for the Benchtop and Enterprise computer systems as system ...
... computer-controlled). · Authoring Corrective & Preventive Action plans (CAPAs) for systems with ... Desired Skills and Experience: · Author, maintain, revise, and/or approve of the Validation Plan ...
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... computer-controlled). · Authoring Corrective & Preventive Action plans (CAPAs) for systems with ... Desired Skills and Experience: · Author, maintain, revise, and/or approve of the Validation Plan ...
... computer-controlled). · Authoring Corrective & Preventive Action plans (CAPAs) for systems with ... Desired Skills and Experience: · Author, maintain, revise, and/or approve of the Validation Plan ...
Quick apply
... computer-controlled). · Authoring Corrective & Preventive Action plans (CAPAs) for systems with ... Desired Skills and Experience: · Author, maintain, revise, and/or approve of the Validation Plan ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
Software Validation Engineer
Northborough, MA · On-site
$95K - $105K/yr
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
Software Validation Engineer
Northborough, MA · On-site
$95K - $105K/yr
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
Validation Engineer II/III (CSV)
Lexington, MA · On-site
$90K - $130K/yr
This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test ...
Validation Engineer II/III (CSV)
Lexington, MA · On-site
$90K - $130K/yr
This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test ...
Validation Engineer II/III (CSV)
$90K - $130K/yr
This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test ...
Quick apply
Validation Engineer II/III (CSV)
$90K - $130K/yr
This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test ...
Validation Engineer II/III (CSV)
Lexington, MA · On-site
$90K - $130K/yr
This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test ...
Validation Engineer II/III (CSV)
Lexington, MA · On-site
$90K - $130K/yr
This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test ...
Computer System Validation information
See Medford, MA salary details
$11.02 - $18.17
2% of jobs
$18.17 - $25.32
9% of jobs
$25.32 - $32.47
1% of jobs
$32.47 - $39.62
4% of jobs
$43.96 is the 25th percentile. Wages below this are outliers.
$39.62 - $46.77
15% of jobs
$46.77 - $53.92
9% of jobs
The median wage is $59.88 / hr.
$53.92 - $61.07
13% of jobs
$66.77 is the 75th percentile. Wages above this are outliers.
$61.07 - $68.22
29% of jobs
$68.22 - $75.37
12% of jobs
$75.37 - $82.53
2% of jobs
$82.53 - $89.68
5% of jobs
$11
$56
$89
How much do computer system validation jobs pay per hour?
What are some typical challenges faced in Computer System Validation roles?
Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.
What is a Computer System Validation job?
A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.
What are the key skills and qualifications needed to thrive in the Computer System Validation position, and why are they important?
To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.
$40/hr
Contractor
Posted 2 days ago
Job description
Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job.
Hands on position responsible for authoring test scripts and other
CSV documents required for the validation of GAMP 5 Category 4
(configurable off the shelf) computer systems. Candidates should be
familiar with COTS systems used for clinical development and quality
activities in a pharmaceutical environment. Work with business users
and Information Technology to ensure the systems remain in a validated
state through appropriate change control procedures. May require
participation in early morning and/or evening teleconferences with
global project teams.
- Create
and/or review computer system validation test scripts, validation
schedules, risk assessments, requirement specifications, protocols and
reports, traceability matrices, and validation summary reports according
to the timelines in the project plan. Review applicable procedures and
system training manuals as applicable. Participate in project team
meeting. (85%) - Document
requirements for business requirements, system security, user roles,
workflows, data flows, GxP requirements and how these systems fit into
the larger IT infrastructure. (10%) - Work
with IT and User Groups to: (a) evaluate change control requests, (b)
assess regulatory risk associated with such requests and (c) determine
the corresponding validation requirements for such changes. (5%)
- 2 - 3 years experience writing CSV test scripts, protocols and summary reports in global environments
- Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline.
Knowledge and skills (general and technical):
- Sufficiently
knowledgeable of FDA/EU/MHLW Regulatory Requirements and industry best
practices for computerized system validation to complete tasks - Experience working with global teams particularly with team members from Japan
- Understands lifecycle approach as well as risk based approach to validation
- Generally familiar with GXP regulations particularly in the GCP and Quality areas
- Able to work both independently and as a member of a cross-functional project team
- Good written and oral communication skills
- Good problem solving skills
- Microsoft products such as Word, Excel, Project, and Visio.
- Familiar
with Information Technology principles, functionalities and
capabilities of computer systems; and how computer systems relate to and
integrate with larger corporate IT infrastructures
$40/hr
6 MONTHS +
About Global Channel Management
Sourced by ZipRecruiter
Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Global Channel Management understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at the same time requiring the best talent for the job. GCM's Ownership and Management teams have extensive Staffing, Recruiting, HR and Executive Leadership knowledge, Experience and Expertise. Our Understanding and Commitment to our Client's Satisfaction are key reasons GCM has been successful in establishing long term relationships.
Industry
Recruiting and staffing services
Company size
11 - 50 Employees
Headquarters location
Austell, GA, US
Year founded
2009