... 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 ...
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 ...
... 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 ...
Devens, MA · On-site
$131K - $159K/yr
Knowledge of Software Development Lifecycle (SDLC) and computer systems validation (CSV) * Ability to quickly learn new technologies and incorporate them into a solution. * Knowledge of Project ...
Devens, MA · On-site
$131K - $159K/yr
Knowledge of Software Development Lifecycle (SDLC) and computer systems validation (CSV) * Ability to quickly learn new technologies and incorporate them into a solution. * Knowledge of Project ...
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 ...
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
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 ...
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 ...
Andover, MA · On-site +1
Automation Validation Lead Location : Andover, MA Duration - 6 months (possible extension ... Ethernet Profibus OPC The ideal candidate should be familiar with the following computer system ...
Andover, MA · On-site +1
Automation Validation Lead Location : Andover, MA Duration - 6 months (possible extension ... Ethernet Profibus OPC The ideal candidate should be familiar with the following computer system ...
$110K - $150K/yr
Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. * Lead implementation of change management of QC instruments, software upgrades, and new ...
$110K - $150K/yr
Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. * Lead implementation of change management of QC instruments, software upgrades, and new ...
$80K - $98K/yr
Lead validation deviation investigations * Assist during the design, evaluation, and risk assessment of new computer systems, equipment, facilities, utilities, processes, and cleaning * Assist during ...
$80K - $98K/yr
Lead validation deviation investigations * Assist during the design, evaluation, and risk assessment of new computer systems, equipment, facilities, utilities, processes, and cleaning * Assist during ...
Milford, MA · On-site
$80K - $98K/yr
Lead validation deviation investigations * Assist during the design, evaluation, and risk assessment of new computer systems, equipment, facilities, utilities, processes, and cleaning * Assist during ...
Milford, MA · On-site
$80K - $98K/yr
Lead validation deviation investigations * Assist during the design, evaluation, and risk assessment of new computer systems, equipment, facilities, utilities, processes, and cleaning * Assist during ...
Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Experience: 3-7+ years of validation experience in a regulated manufacturing environment with ...
Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Experience: 3-7+ years of validation experience in a regulated manufacturing environment with ...
Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Experience: 3-7+ years of validation experience in a regulated manufacturing environment with ...
Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Experience: 3-7+ years of validation experience in a regulated manufacturing environment with ...
Devens, MA · On-site
Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Experience: 3-7+ years of validation experience in a regulated manufacturing environment with ...
Devens, MA · On-site
Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Experience: 3-7+ years of validation experience in a regulated manufacturing environment with ...
Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Experience: 3-7+ years of validation experience in a regulated manufacturing environment with ...
Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Experience: 3-7+ years of validation experience in a regulated manufacturing environment with ...
$110K - $150K/yr
Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. * Lead implementation of change management of QC instruments, software upgrades, and new ...
Quick apply
$110K - $150K/yr
Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. * Lead implementation of change management of QC instruments, software upgrades, and new ...
Lexington, MA · On-site
$110K - $150K/yr
Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. * Lead implementation of change management of QC instruments, software upgrades, and new ...
Lexington, MA · On-site
$110K - $150K/yr
Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. * Lead implementation of change management of QC instruments, software upgrades, and new ...
Computer system validation (CSV) * Process validation Utility qualification (WFI, purified water, clean steam, HVAC) * Environmental monitoring systems * Provide technical guidance and ...
Computer system validation (CSV) * Process validation Utility qualification (WFI, purified water, clean steam, HVAC) * Environmental monitoring systems * Provide technical guidance and ...
Boston, MA · On-site
Computer system validation (CSV) * Process validation Utility qualification (WFI, purified water, clean steam, HVAC) * Environmental monitoring systems * Provide technical guidance and ...
Boston, MA · On-site
Computer system validation (CSV) * Process validation Utility qualification (WFI, purified water, clean steam, HVAC) * Environmental monitoring systems * Provide technical guidance and ...
Boston, MA · On-site
Computer system validation (CSV) * Process validation Utility qualification (WFI, purified water, clean steam, HVAC) * Environmental monitoring systems * Provide technical guidance and ...
Boston, MA · On-site
Computer system validation (CSV) * Process validation Utility qualification (WFI, purified water, clean steam, HVAC) * Environmental monitoring systems * Provide technical guidance and ...
Boston, MA · On-site
Computer system validation (CSV) * Process validation Utility qualification (WFI, purified water, clean steam, HVAC) * Environmental monitoring systems * Provide technical guidance and ...
Boston, MA · On-site
Computer system validation (CSV) * Process validation Utility qualification (WFI, purified water, clean steam, HVAC) * Environmental monitoring systems * Provide technical guidance and ...
$11.55 - $19.05
2% of jobs
$19.05 - $26.54
9% of jobs
$26.54 - $34.03
1% of jobs
$34.03 - $41.53
4% of jobs
$46.08 is the 25th percentile. Wages below this are outliers.
$41.53 - $49.02
15% of jobs
$49.02 - $56.52
9% of jobs
The median wage is $62.76 / hr.
$56.52 - $64.01
13% of jobs
$69.98 is the 75th percentile. Wages above this are outliers.
$64.01 - $71.50
29% of jobs
$71.50 - $79
12% of jobs
$79 - $86.49
2% of jobs
$86.49 - $93.99
5% of jobs
$11
$59
$93
| Aspect | Computer Systems Validation | Quality Assurance Specialist |
|---|---|---|
| Certifications | GAMP, CSV-specific training | ISO 9001, Six Sigma |
| Work Environment | Regulated industries like pharma, biotech | Manufacturing, software, service sectors |
| Primary Focus | Ensuring computer systems meet regulatory standards | Ensuring overall product/service quality |
| Common Usage | Validation of software, hardware in compliance | Process audits, quality improvement |
Computer Systems Validation and Quality Assurance Specialist roles overlap in ensuring compliance and quality. However, CSV focuses specifically on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. Quality Assurance Specialists have a broader scope, overseeing overall quality processes across various sectors. Both roles require similar certifications and work environments but differ in their primary objectives and specific tasks.

Contractor
Medical, Dental, Vision
Posted 16 days ago
Responsibilities:
· Provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for the implementation of analytical assays on new instrumentation. This scope includes QC Instruments (both portable and computer-controlled).
· Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final reports for systems with short-term/completed remediation
· Performing supporting remediation work in the form of SOP revisions
· Executing change controls and validation test plans/protocols when required per remediation plans
· Responsible for the development and execution of general deliverables, such as Risk Assessments, Validation Plans, Change Impact Assessments, Design Specifications, User Requirements, Functional Requirements, Configuration Specification, Requirement Trace Matrices, IQ/OQ/UAT/PQ Protocols, and Summary Reports.
Desired Skills and Experience:
· Author, maintain, revise, and/or approve of the Validation Plan.
· Lead the resolution of deviations noted during protocol execution.
· Manage and approve vendor’s documentation as appropriate.
· Ability to impact and influence people/areas in matters related to Validation and GxP compliance.
· Ability to work in a fast-moving dynamic small company environment.
· Ability to mentor junior team members.
· Experiences in other validation areas which may include CSV qualification and Facility Equipment and Utility is a plus.
Required Qualifications:
· Validation experience in a biotech/pharmaceutical environment, specializing in Instrument or Computer System Validation
· Bachelor's Degree in Engineering, Life Science or Computer Science is required.
· Excellent working knowledge of process automation and computer system validation concepts, GAMP methodologies, CFR Part 11 Electronic Records and Signatures requirements and latest industry expectations for data integrity.
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