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 ...
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 ...
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 ...
The Computer Systems Validation Engineer supports validation lifecycle activities for automation and control systems within a regulated pharmaceutical manufacturing environment. This role works ...
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The Computer Systems Validation Engineer supports validation lifecycle activities for automation and control systems within a regulated pharmaceutical manufacturing environment. This role works ...
The Computer Systems Validation Engineer supports validation lifecycle activities for automation and control systems within a regulated pharmaceutical manufacturing environment. This role works ...
The Computer Systems Validation Engineer supports validation lifecycle activities for automation and control systems within a regulated pharmaceutical manufacturing environment. This role works ...
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 ...
Senior Computer System Validation Consultant
San Diego, CA · On-site
$23 - $28/hr
The role involves leading computer system validation activities across the system lifecycle, ensuring regulatory compliance, data integrity, and quality governance in a biopharmaceutical environment ...
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Senior Computer System Validation Consultant
San Diego, CA · On-site
$23 - $28/hr
The role involves leading computer system validation activities across the system lifecycle, ensuring regulatory compliance, data integrity, and quality governance in a biopharmaceutical environment ...
Author documents related to GxP Systems Draft Requirements and computer systems validation documents using GAMP 5 Execute test protocols for the software validation. Initiate and execute change ...
Author documents related to GxP Systems Draft Requirements and computer systems validation documents using GAMP 5 Execute test protocols for the software validation. Initiate and execute change ...
Draft Requirements and computer systems validation documents using GAMP 5 * Execute test protocols for the software validation. * Initiate and execute change management for existing qualified systems.
Draft Requirements and computer systems validation documents using GAMP 5 * Execute test protocols for the software validation. * Initiate and execute change management for existing qualified systems.
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 ...
Computer System Validation Engineer
Tustin, CA · On-site
$104.40K/yr
Computer System Validation Engineer Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial ...
Computer System Validation Engineer
Tustin, CA · On-site
$104.40K/yr
Computer System Validation Engineer Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial ...
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.
Job Summary of the Sr. Engineer, Computer System Validation The Sr. Engineer, Computer System Validation, will demonstrate strong expertise in Computer System Validation (CSV), data integrity, and ...
Job Summary of the Sr. Engineer, Computer System Validation The Sr. Engineer, Computer System Validation, will demonstrate strong expertise in Computer System Validation (CSV), data integrity, and ...
Job Summary of the Sr. Engineer, Computer System Validation The Sr. Engineer, Computer System Validation, will demonstrate strong expertise in Computer System Validation (CSV), data integrity, and ...
Job Summary of the Sr. Engineer, Computer System Validation The Sr. Engineer, Computer System Validation, will demonstrate strong expertise in Computer System Validation (CSV), data integrity, 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 ...
Job Summary of the Sr. Engineer, Computer System Validation The Sr. Engineer, Computer System Validation, will demonstrate strong expertise in Computer System Validation (CSV), data integrity, and ...
Job Summary of the Sr. Engineer, Computer System Validation The Sr. Engineer, Computer System Validation, will demonstrate strong expertise in Computer System Validation (CSV), data integrity, and ...
Position Summary The Computer System Validation (CSV) role is responsible for developing, executing, and maintaining validation documentation to ensure IT systems comply with local and global ...
Position Summary The Computer System Validation (CSV) role is responsible for developing, executing, and maintaining validation documentation to ensure IT systems comply with local and global ...
Job Title: CSV Lead - Computer System Validation Location: Lancaster, PA Experience: 1O-20 Years Job Type: Long-Term Contract Work Model: Onsite Job Summary: Seeking an experienced CSV Lead to ...
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Job Title: CSV Lead - Computer System Validation Location: Lancaster, PA Experience: 1O-20 Years Job Type: Long-Term Contract Work Model: Onsite Job Summary: Seeking an experienced CSV Lead to ...
Computer System Validation Engineer
$82K - $104.40K/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 Engineer
$82K - $104.40K/yr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
Senior Specialist, Computer System Validation
Syracuse, NY · On-site
$60K - $88K/yr
Position Summary The Computer System Validation (CSV) role is responsible for developing, executing, and maintaining validation documentation to ensure IT systems comply with local and global ...
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Senior Specialist, Computer System Validation
Syracuse, NY · On-site
$60K - $88K/yr
Position Summary The Computer System Validation (CSV) role is responsible for developing, executing, and maintaining validation documentation to ensure IT systems comply with local and global ...
Senior Specialist, Computer System Validation
Syracuse, NY · On-site
$60K - $88K/yr
Position Summary The Computer System Validation (CSV) role is responsible for developing, executing, and maintaining validation documentation to ensure IT systems comply with local and global ...
Senior Specialist, Computer System Validation
Syracuse, NY · On-site
$60K - $88K/yr
Position Summary The Computer System Validation (CSV) role is responsible for developing, executing, and maintaining validation documentation to ensure IT systems comply with local and global ...
Computer System Validation information
See salary details
$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
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Full-time
Posted 22 days ago
Job description
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:
- 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 Validation Life Cycle. Documentation includes Computer System Validation Plan, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.
- Track and resolve deviations/exceptions during qualification activities.
- Work with company management to implement changes and upgrades to computer systems
- Work with vendors on purchasing and planning for new lab equipment/software upgrades, review vendor protocols/design specifications
- Communicate Computer System Validation approaches and requirements during audits.
- Review validated systems to assess need for further enhancements, validation, or system upgrades/fixes
Qualifications:
- Two (2) years of experience with Computer System Validation in GxP environment (preferably pharmaceutical industry).
- Experience in writing computer system test scripts, validation protocols and summary reports
Knowledge of Regulatory Requirements, 21CFR11, Data Integrity Guidance, GAMP and industry best practices for validation to complete tasks - Proficient in analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution
- Capable of managing multiple sub-projects, duties and tasks
- Effective at communicating clearly and concisely, both orally and in writing
- Able to work both independently and as a member of a cross-functional project team 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. recblid qiiwidbk93yn3ugmmm40b8rd1l0rfa
About QUALITY CHEMICAL LABORATORIES
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
51 - 200 Employees
Headquarters location
Wilmington, NC, US
Year founded
1998