... validation, administration, data management, user support, troubleshooting cross Frontage lab to meet GxP requirements on computer systems in lab. Roles & Responsibilities: * Ensure Frontage lab ...
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... validation, administration, data management, user support, troubleshooting cross Frontage lab to meet GxP requirements on computer systems in lab. Roles & Responsibilities: * Ensure Frontage lab ...
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... validation, administration, data management, user support, troubleshooting cross Frontage lab to meet GxP requirements on computer systems in lab. Roles & Responsibilities: * Ensure Frontage lab ...
Service requests, incident resolution, release management, minor enhancement on list of regulatory submission applications. • Performing Computer System Validation activities and authoring ...
Service requests, incident resolution, release management, minor enhancement on list of regulatory submission applications. • Performing Computer System Validation activities and authoring ...
Lead Computer System Validation (CSV) processes ensuring all MES applications meet regulatory standards. * Ensure compliance with FDA 21 CFR Part 11 and GAMP guidelines . * Manage validation ...
Lead Computer System Validation (CSV) processes ensuring all MES applications meet regulatory standards. * Ensure compliance with FDA 21 CFR Part 11 and GAMP guidelines . * Manage validation ...
King Of Prussia, PA · On-site +1
$70K - $118K/yr
Guide testing readiness activities, CMDB governance, and validation tool utilization while ensuring ... Computer System Validation (CSV) / Computer System Assurance within regulated life sciences
King Of Prussia, PA · On-site +1
$70K - $118K/yr
Guide testing readiness activities, CMDB governance, and validation tool utilization while ensuring ... Computer System Validation (CSV) / Computer System Assurance within regulated life sciences
King Of Prussia, PA · On-site +1
$70K - $118K/yr
Guide testing readiness activities, CMDB governance, and validation tool utilization while ensuring ... Computer System Validation (CSV) / Computer System Assurance within regulated life sciences
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King Of Prussia, PA · On-site +1
$70K - $118K/yr
Guide testing readiness activities, CMDB governance, and validation tool utilization while ensuring ... Computer System Validation (CSV) / Computer System Assurance within regulated life sciences
King Of Prussia, PA · On-site
$65/hr
King of Prussia, PA Mode (TP/FTE) TP Mandatory Skills Computer System Validation, Computed system assurance, GAMP,GxP risk assessments,Change Management JD 12+ years' Experience in Validating systems ...
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King Of Prussia, PA · On-site
$65/hr
King of Prussia, PA Mode (TP/FTE) TP Mandatory Skills Computer System Validation, Computed system assurance, GAMP,GxP risk assessments,Change Management JD 12+ years' Experience in Validating systems ...
Lead Computer System Validation (CSV) processes ensuring all MES applications meet regulatory standards. * Ensure compliance with FDA 21 CFR Part 11 and GAMP guidelines . * Manage validation ...
Lead Computer System Validation (CSV) processes ensuring all MES applications meet regulatory standards. * Ensure compliance with FDA 21 CFR Part 11 and GAMP guidelines . * Manage validation ...
Lead Computer System Validation (CSV) processes ensuring all MES applications meet regulatory standards. * Ensure compliance with FDA 21 CFR Part 11 and GAMP guidelines . * Manage validation ...
Lead Computer System Validation (CSV) processes ensuring all MES applications meet regulatory standards. * Ensure compliance with FDA 21 CFR Part 11 and GAMP guidelines . * Manage validation ...
Lead system lifecycle management activities, including configuration, upgrades, patching, change ... Lead computer system validation activities in accordance with FDA, EMA, GAMP 5, and internal ...
Lead system lifecycle management activities, including configuration, upgrades, patching, change ... Lead computer system validation activities in accordance with FDA, EMA, GAMP 5, and internal ...
Lead system lifecycle management activities, including configuration, upgrades, patching, change ... Lead computer system validation activities in accordance with FDA, EMA, GAMP 5, and internal ...
Lead system lifecycle management activities, including configuration, upgrades, patching, change ... Lead computer system validation activities in accordance with FDA, EMA, GAMP 5, and internal ...
It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation ...
It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation ...
Investigation and deviation management experience. * Demonstrated proficiency in computer system validation. * Experience with compliance requirements and regulatory expectations. * Demonstrated ...
Investigation and deviation management experience. * Demonstrated proficiency in computer system validation. * Experience with compliance requirements and regulatory expectations. * Demonstrated ...
Manage end to end lab system lifecycle including implementation validation maintenance and ... Computer System Validation. • Good understanding of laboratory instruments and analytical ...
Manage end to end lab system lifecycle including implementation validation maintenance and ... Computer System Validation. • Good understanding of laboratory instruments and analytical ...
It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation ...
It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation ...
Investigation and deviation management experience. * Demonstrated proficiency in computer system validation. * Experience with compliance requirements and regulatory expectations. * Demonstrated ...
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Investigation and deviation management experience. * Demonstrated proficiency in computer system validation. * Experience with compliance requirements and regulatory expectations. * Demonstrated ...
Significant experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA ... Requirements management * Test planning and execution * Traceability * Deviation management
Significant experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA ... Requirements management * Test planning and execution * Traceability * Deviation management
Validation Engineer (CQV) Location: Raleigh-Durham area, NC Position Overview We are seeking an ... Ability to manage multiple systems and priorities during commissioning/startup phases Work ...
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Validation Engineer (CQV) Location: Raleigh-Durham area, NC Position Overview We are seeking an ... Ability to manage multiple systems and priorities during commissioning/startup phases Work ...
King Of Prussia, PA · On-site
Significant experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA ... Requirements management * Test planning and execution * Traceability * Deviation management
King Of Prussia, PA · On-site
Significant experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA ... Requirements management * Test planning and execution * Traceability * Deviation management
Significant experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA ... Requirements management * Test planning and execution * Traceability * Deviation management
Quick apply
Significant experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA ... Requirements management * Test planning and execution * Traceability * Deviation management
King Of Prussia, PA · On-site
$60/hr
Clear understanding of various levels of IT applications from development, testing, and computer system validation. Ability to follow valid templates. Rapid turnover of deliverables are required.
King Of Prussia, PA · On-site
$60/hr
Clear understanding of various levels of IT applications from development, testing, and computer system validation. Ability to follow valid templates. Rapid turnover of deliverables are required.
$47.6K - $57.9K
1% of jobs
$57.9K - $68.2K
4% of jobs
$76.8K is the 25th percentile. Wages below this are outliers.
$68.2K - $78.5K
24% of jobs
$78.5K - $88.8K
9% of jobs
The median wage is $96.2K / yr.
$88.8K - $99.1K
17% of jobs
$99.1K - $109.4K
8% of jobs
$109.4K - $119.7K
5% of jobs
$126.6K is the 75th percentile. Wages above this are outliers.
$119.7K - $130K
11% of jobs
$130K - $140.3K
8% of jobs
$140.3K - $150.6K
6% of jobs
$150.6K - $160.9K
8% of jobs
$47.6K
$105.7K
$160.9K
| Aspect | Computer System Validation Manager | Computer System Validation Specialist |
|---|---|---|
| Certifications | GAMP, CQE, CSQE | GAMP, CQE, CSQE |
| Work Environment | Management, oversight, strategic planning | Execution, testing, documentation |
| Industry Usage | Pharmaceutical, biotech, regulated industries | Pharmaceutical, biotech, regulated industries |
| Primary Focus | Leading validation projects, team coordination | Performing validation activities, testing |
The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

Full-time
Medical, Dental, Life, Retirement
Posted 25 days ago
CSV and Lab Application Support Specialist
Title: CSV and Lab Application Specialist
Location: Exton, PA
Reports to: Senior Director IT Infrastructure
Full-time (40 hrs./week) on site
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
As subject matter expert (SME), the CSV and lab application specialist define and maintain Frontage lab computer system validation program and responsible for testing, implementation, validation and date to date support of software applications.
The primary responsibilities of this position will be to perform lab software/application implementation and validation, administration, data management, user support, troubleshooting cross Frontage lab to meet GxP requirements on computer systems in lab.
Roles & Responsibilities:
Education, Experience & Skills Required:
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
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Pharmaceutical and medicine manufacturing
201 - 500 Employees
Exton, PA, US
2001