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 ...
Durham, NC · On-site
$133K - $183K/yr
Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment. Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as ...
Durham, NC · On-site
$133K - $183K/yr
Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment. Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as ...
Durham, NC · On-site
$133K - $183K/yr
Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment. Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as ...
Durham, NC · On-site
$133K - $183K/yr
Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment. Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as ...
Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer ...
Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer ...
Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer ...
Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer ...
Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer ...
Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer ...
The role demands deep technical expertise across the full validation lifecycle -- including URS development, FAT/SAT execution, and Computer System Validation (CSV) -- as well as hands-on experience ...
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The role demands deep technical expertise across the full validation lifecycle -- including URS development, FAT/SAT execution, and Computer System Validation (CSV) -- as well as hands-on experience ...
The role demands deep technical expertise across the full validation lifecycle -- including URS development, FAT/SAT execution, and Computer System Validation (CSV) -- as well as hands-on experience ...
Quick apply
The role demands deep technical expertise across the full validation lifecycle -- including URS development, FAT/SAT execution, and Computer System Validation (CSV) -- as well as hands-on experience ...
The role demands deep technical expertise across the full validation lifecycle including URS development, FAT/SAT execution, and Computer System Validation (CSV) as well as hands-on experience with ...
The role demands deep technical expertise across the full validation lifecycle including URS development, FAT/SAT execution, and Computer System Validation (CSV) as well as hands-on experience with ...
Company Description Skye Blue Consulting has been engaged to find a Computer systems validation supervisor for one of our top clients in Western North Carolina. The client is a small (but growing ...
Company Description Skye Blue Consulting has been engaged to find a Computer systems validation supervisor for one of our top clients in Western North Carolina. The client is a small (but growing ...
Hickory, NC · On-site
Company Description Skye Blue Consulting has been engaged to find a Computer systems validation supervisor for one of our top clients in Western North Carolina. The client is a small (but growing ...
Hickory, NC · On-site
Company Description Skye Blue Consulting has been engaged to find a Computer systems validation supervisor for one of our top clients in Western North Carolina. The client is a small (but growing ...
You will partner closely with automation, manufacturing, and quality teams to evaluate system ... Exposure to Computer Systems Validation (CSV), CQV, or automation validation * Familiarity with ...
You will partner closely with automation, manufacturing, and quality teams to evaluate system ... Exposure to Computer Systems Validation (CSV), CQV, or automation validation * Familiarity with ...
You will partner closely with automation, manufacturing, and quality teams to evaluate system ... Exposure to Computer Systems Validation (CSV), CQV, or automation validation * Familiarity with ...
You will partner closely with automation, manufacturing, and quality teams to evaluate system ... Exposure to Computer Systems Validation (CSV), CQV, or automation validation * Familiarity with ...
Join our validation engineering team as a Validation Engineer III (Computer Systems Validation ... You will evaluate system and process changes, determine validation impact, and drive qualification ...
Join our validation engineering team as a Validation Engineer III (Computer Systems Validation ... You will evaluate system and process changes, determine validation impact, and drive qualification ...
Join our validation engineering team as a Validation Engineer III (Computer Systems Validation ... You will evaluate system and process changes, determine validation impact, and drive qualification ...
Join our validation engineering team as a Validation Engineer III (Computer Systems Validation ... You will evaluate system and process changes, determine validation impact, and drive qualification ...
... 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 ...
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... 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 ...
The Position Provide subject matter expertise in Computer Systems Validation, process improvement ... Maintain system documentation and process according to Novo Nordisk standards and in compliance ...
The Position Provide subject matter expertise in Computer Systems Validation, process improvement ... Maintain system documentation and process according to Novo Nordisk standards and in compliance ...
The Position Provide subject matter expertise in Computer Systems Validation, process improvement ... Maintain system documentation and process according to Novo Nordisk standards and in compliance ...
The Position Provide subject matter expertise in Computer Systems Validation, process improvement ... Maintain system documentation and process according to Novo Nordisk standards and in compliance ...
The Position Provide subject matter expertise in Computer Systems Validation, process improvement ... Maintain system documentation and process according to Novo Nordisk standards and in compliance ...
The Position Provide subject matter expertise in Computer Systems Validation, process improvement ... Maintain system documentation and process according to Novo Nordisk standards and in compliance ...
Quality/Validation Engineer III / Laboratory Instrument Validation Duration: 09 months contract ... Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.). Demonstrated ability to ...
Quality/Validation Engineer III / Laboratory Instrument Validation Duration: 09 months contract ... Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.). Demonstrated ability to ...
$9.61 - $15.85
2% of jobs
$15.85 - $22.08
9% of jobs
$22.08 - $28.32
1% of jobs
$28.32 - $34.56
4% of jobs
$38.34 is the 25th percentile. Wages below this are outliers.
$34.56 - $40.79
15% of jobs
$40.79 - $47.03
9% of jobs
The median wage is $52.23 / hr.
$47.03 - $53.27
13% of jobs
$58.23 is the 75th percentile. Wages above this are outliers.
$53.27 - $59.50
29% of jobs
$59.50 - $65.74
12% of jobs
$65.74 - $71.97
2% of jobs
$71.97 - $78.21
5% of jobs
$9
$49
$78
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
Posted 8 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