Work with company management to implement changes and upgrades to computer systems * Work with ... Communicate Computer System Validation approaches and requirements during audits. * Review ...
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Work with company management to implement changes and upgrades to computer systems * Work with ... Communicate Computer System Validation approaches and requirements during audits. * Review ...
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Work with company management to implement changes and upgrades to computer systems * Work with ... Communicate Computer System Validation approaches and requirements during audits. * Review ...
We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification, and GMP-regulated environments. The ideal candidate will support validation ...
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We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification, and GMP-regulated environments. The ideal candidate will support validation ...
Westborough, MA · On-site
$105K - $150K/yr
Principal Computer System Validation Specialist About Astellas Astellas is a global life sciences ... Manage audit readiness for all validated systems; support internal and external inspections (FDA ...
Westborough, MA · On-site
$105K - $150K/yr
Principal Computer System Validation Specialist About Astellas Astellas is a global life sciences ... Manage audit readiness for all validated systems; support internal and external inspections (FDA ...
$82K - $104K/yr
Your Role: The Computer System Validation Engineer is responsible for providing technical ... manager in developing realistic time and resource requirements for validation activities in support ...
$82K - $104K/yr
Your Role: The Computer System Validation Engineer is responsible for providing technical ... manager in developing realistic time and resource requirements for validation activities in support ...
This role will focus on computer systems validation, revalidation efforts, data migration activities, and documentation management for critical business and quality systems. The ideal candidate will ...
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This role will focus on computer systems validation, revalidation efforts, data migration activities, and documentation management for critical business and quality systems. The ideal candidate will ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing ... Experience in managing large implementations/upgrade project * Strong knowledge on change ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing ... Experience in managing large implementations/upgrade project * Strong knowledge on change ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing ... Experience in managing large implementations/upgrade project * Strong knowledge on change ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing ... Experience in managing large implementations/upgrade project * Strong knowledge on change ...
Change Control & Lifecycle Management * Support system changes through formal change control ... Minimum of 5 years in Computer System Validation in GMP-regulated pharmaceutical or biotech ...
Change Control & Lifecycle Management * Support system changes through formal change control ... Minimum of 5 years in Computer System Validation in GMP-regulated pharmaceutical or biotech ...
Change Control & Lifecycle Management * Support system changes through formal change control ... Minimum of 5 years in Computer System Validation in GMP-regulated pharmaceutical or biotech ...
Change Control & Lifecycle Management * Support system changes through formal change control ... Minimum of 5 years in Computer System Validation in GMP-regulated pharmaceutical or biotech ...
Computer Systems Validation (CSV) Specialist Location : Portsmouth, NH. Relocation assistance is ... Experience leading projects and managing CAPAs and deviations. * Background in biotech, pharma, or ...
Computer Systems Validation (CSV) Specialist Location : Portsmouth, NH. Relocation assistance is ... Experience leading projects and managing CAPAs and deviations. * Background in biotech, pharma, or ...
Computer Systems Validation (CSV) Specialist Location : Portsmouth, NH. Relocation assistance is ... Experience leading projects and managing CAPAs and deviations. * Background in biotech, pharma, or ...
Computer Systems Validation (CSV) Specialist Location : Portsmouth, NH. Relocation assistance is ... Experience leading projects and managing CAPAs and deviations. * Background in biotech, pharma, or ...
Author/Review/Approve all end to end Computer system validation life- * cycle deliverables/activities. * Schedule qualification activities and personnel to meet business, * manufacturing, engineering ...
Author/Review/Approve all end to end Computer system validation life- * cycle deliverables/activities. * Schedule qualification activities and personnel to meet business, * manufacturing, engineering ...
Author/Review/Approve all end to end Computer system validation life- * cycle deliverables/activities. * Schedule qualification activities and personnel to meet business, * manufacturing, engineering ...
Author/Review/Approve all end to end Computer system validation life- * cycle deliverables/activities. * Schedule qualification activities and personnel to meet business, * manufacturing, engineering ...
Author/Review/Approve all end to end Computer system validation life- * cycle deliverables/activities. * Schedule qualification activities and personnel to meet business, * manufacturing, engineering ...
Author/Review/Approve all end to end Computer system validation life- * cycle deliverables/activities. * Schedule qualification activities and personnel to meet business, * manufacturing, engineering ...
Author/Review/Approve all end to end Computer system validation life- * cycle deliverables/activities. * Schedule qualification activities and personnel to meet business, * manufacturing, engineering ...
Author/Review/Approve all end to end Computer system validation life- * cycle deliverables/activities. * Schedule qualification activities and personnel to meet business, * manufacturing, engineering ...
COMPUTER SYSTEM VALIDATION LEAD Wilmington, DE Fulltime 10+ years of experience Must Have ... Working knowledge of change control, deviation management, CAPA, and periodic review. * Good ...
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COMPUTER SYSTEM VALIDATION LEAD Wilmington, DE Fulltime 10+ years of experience Must Have ... Working knowledge of change control, deviation management, CAPA, and periodic review. * Good ...
Our account managers and recruiters have over a decade of experience in various verticals. GCM ... Candidates should be familiar with COTS systems used for clinical development and quality ...
Our account managers and recruiters have over a decade of experience in various verticals. GCM ... Candidates should be familiar with COTS systems used for clinical development and quality ...
Seattle, WA · On-site
Computer System Validation (CSV - GAMP 5, 21 CFR Part 11) * Shipping / Distribution Validation * Proven leadership and team management experience * Deep understanding of FDA 21 CFR, EU GMP, and ICH ...
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Seattle, WA · On-site
Computer System Validation (CSV - GAMP 5, 21 CFR Part 11) * Shipping / Distribution Validation * Proven leadership and team management experience * Deep understanding of FDA 21 CFR, EU GMP, and ICH ...
$107K - $127K/yr
Candidate will take direction from Lead Automation Engineer/Project Manager. Execute Computer System validation (CSV) protocols. Write and resolve protocol deviations. Write test summary reports.
$107K - $127K/yr
Candidate will take direction from Lead Automation Engineer/Project Manager. Execute Computer System validation (CSV) protocols. Write and resolve protocol deviations. Write test summary reports.
As a Quality Assurance Validation Manager, you will provide leadership and oversight for validation programs across equipment, utilities, facilities, computer systems, cleaning processes, analytical ...
As a Quality Assurance Validation Manager, you will provide leadership and oversight for validation programs across equipment, utilities, facilities, computer systems, cleaning processes, analytical ...
$47.5K - $57.8K
1% of jobs
$57.8K - $68K
4% of jobs
$76.6K is the 25th percentile. Wages below this are outliers.
$68K - $78.3K
24% of jobs
$78.3K - $88.6K
9% of jobs
The median wage is $96K / yr.
$88.6K - $98.9K
17% of jobs
$98.9K - $109.1K
8% of jobs
$109.1K - $119.4K
5% of jobs
$126.3K is the 75th percentile. Wages above this are outliers.
$119.4K - $129.7K
11% of jobs
$129.7K - $140K
8% of jobs
$140K - $150.2K
6% of jobs
$150.2K - $160.5K
8% of jobs
$47.5K
$105.4K
$160.5K
| 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
Re-posted 21 days ago
Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Computer System Validation Specialist.
Responsibilities:
Qualifications:
Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers.
QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility.
QCL is an equal opportunity employer.
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Pharmaceutical and medicine manufacturing
51 - 200 Employees
Wilmington, NC, US
1998