Performs and leads computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 ...
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Performs and leads computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 ...
Quick apply
Performs and leads computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 ...
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 ...
The role involves leading end-to-end Computer System Validation activities, ensuring compliance with regulations and quality procedures in regulated environments. Responsibilities : • Lead and ...
The role involves leading end-to-end Computer System Validation activities, ensuring compliance with regulations and quality procedures in regulated environments. Responsibilities : • Lead and ...
Company Description * Computer System Validation (CSV) of SAP (ERP) system to meet GxP compliance. * Validation is lean and risk based and is being built on previous validation deliverables.
Company Description * Computer System Validation (CSV) of SAP (ERP) system to meet GxP compliance. * Validation is lean and risk based and is being built on previous validation deliverables.
Computer Validation Specialist-PQM Location: Fort Worth, TX Company: PharmEng Technology Inc ... Drive continuous improvement of the quality system to meet and sustain compliance with internal and ...
Computer Validation Specialist-PQM Location: Fort Worth, TX Company: PharmEng Technology Inc ... Drive continuous improvement of the quality system to meet and sustain compliance with internal and ...
Travel to site is required. and Qualification: * 3 to 5+ years of Computer systems validation (CSV) experience in computerized equipment, QC lab and manufacturing systems is required * Author, review ...
Travel to site is required. and Qualification: * 3 to 5+ years of Computer systems validation (CSV) experience in computerized equipment, QC lab and manufacturing systems is required * Author, review ...
Westborough, MA · On-site
$105K - $150K/yr
Principal Computer System Validation Specialist About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative ...
New
Westborough, MA · On-site
$105K - $150K/yr
Principal Computer System Validation Specialist About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative ...
New
Tustin, CA · On-site
$82K - $104K/yr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
Tustin, CA · On-site
$82K - $104K/yr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
Computer System Validation (CSV) Lead Location: Lancaster, PA Position Summary We are seeking an experienced Computer System Validation (CSV) Lead to support validation activities for a newly ...
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Computer System Validation (CSV) Lead Location: Lancaster, PA Position Summary We are seeking an experienced Computer System Validation (CSV) Lead to support validation activities for a newly ...
Wilmington, DE · On-site
$100K - $120K/yr
Must Have Technical/Functional Skill • 810 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech). • Hands-on experience with ...
Wilmington, DE · On-site
$100K - $120K/yr
Must Have Technical/Functional Skill • 810 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech). • Hands-on experience with ...
... validation exceptions/deviations for Computer and IT systems. b. Expertise in MES/Delta-V/LIMS/Lab Equipment and Manufacturing CSV systems. Schedules and executes validations per ASTM, GAMP V ...
... validation exceptions/deviations for Computer and IT systems. b. Expertise in MES/Delta-V/LIMS/Lab Equipment and Manufacturing CSV systems. Schedules and executes validations per ASTM, GAMP V ...
Tustin, CA · On-site
$82K - $104K/yr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
Tustin, CA · On-site
$82K - $104K/yr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
CSV Consultant (Computer Systems Validation) Location: Redwood City, CA Type: Contract Job Summary We are seeking an experienced CSV Consultant to support validation activities across multiple GxP ...
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CSV Consultant (Computer Systems Validation) Location: Redwood City, CA Type: Contract Job Summary We are seeking an experienced CSV Consultant to support validation activities across multiple GxP ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
Cognizant is seeking a Computer System Validation (CSV) Lead to lead validation and testing activities for regulated systems. The role involves ensuring compliance with industry standards and ...
Cognizant is seeking a Computer System Validation (CSV) Lead to lead validation and testing activities for regulated systems. The role involves ensuring compliance with industry standards and ...
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Philadelphia, PA · Remote
$70 - $75/hr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
New
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Be Seen First
Philadelphia, PA · Remote
$70 - $75/hr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
New
* Provide QA oversight for computer system validation activities across Veeva Vault, LIMS, ERP, Clinical Systems, and other GxP-regulated applications. * Review and approve validation lifecycle ...
* Provide QA oversight for computer system validation activities across Veeva Vault, LIMS, ERP, Clinical Systems, and other GxP-regulated applications. * Review and approve validation lifecycle ...
Be Seen First
Philadelphia, PA · Remote
$70 - $75/hr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
New
Quick apply
Be Seen First
Philadelphia, PA · Remote
$70 - $75/hr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
New
Chicago, IL · On-site
$83K - $131K/yr
About the Role As a Computer System Validation (CSV) Lead , you will make an impact by leading validation and testing activities for regulated systems while ensuring compliance with industry ...
Chicago, IL · On-site
$83K - $131K/yr
About the Role As a Computer System Validation (CSV) Lead , you will make an impact by leading validation and testing activities for regulated systems while ensuring compliance with industry ...
$10.58 - $17.44
2% of jobs
$17.44 - $24.30
9% of jobs
$24.30 - $31.16
1% of jobs
$31.16 - $38.02
4% of jobs
$42.19 is the 25th percentile. Wages below this are outliers.
$38.02 - $44.89
15% of jobs
$44.89 - $51.75
9% of jobs
The median wage is $57.47 / hr.
$51.75 - $58.61
13% of jobs
$64.07 is the 75th percentile. Wages above this are outliers.
$58.61 - $65.47
29% of jobs
$65.47 - $72.33
12% of jobs
$72.33 - $79.20
2% of jobs
$79.20 - $86.06
5% of jobs
$10
$54
$86
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.
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.
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.

Full-time
Re-posted 27 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