Computer System Validation
Raritan, NJ ยท On-site
Role: Validation Lead(Computer System Validation - GenAI, Agentic QMS) Location: Raritan, NJ(Hybrid) Duration: 12 Months * Experience with Validation of GEN AI solutions in GxP environment is key.
Raritan, NJ ยท On-site
Role: Validation Lead(Computer System Validation - GenAI, Agentic QMS) Location: Raritan, NJ(Hybrid) Duration: 12 Months * Experience with Validation of GEN AI solutions in GxP environment is key.
Raritan, NJ ยท On-site
Role: Validation Lead(Computer System Validation - GenAI, Agentic QMS) Location: Raritan, NJ(Hybrid) Duration: 12 Months * Experience with Validation of GEN AI solutions in GxP environment is key.
Somerville, NJ ยท On-site
$135K - $180K/yr
The leader of Computer System Validation and Computer Software Assurance (CSV/CSA) is responsible for leading and governing all site-wide CSV and CSA activities to ensure that computerized systems ...
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Somerville, NJ ยท On-site
$135K - $180K/yr
The leader of Computer System Validation and Computer Software Assurance (CSV/CSA) is responsible for leading and governing all site-wide CSV and CSA activities to ensure that computerized systems ...
Princeton, NJ ยท On-site
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
Princeton, NJ ยท On-site
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
Princeton, NJ ยท On-site
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
Princeton, NJ ยท On-site
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems * Support CSV activities across lab instruments ...
Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems * Support CSV activities across lab instruments ...
Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems * Support CSV activities across lab instruments ...
Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems * Support CSV activities across lab instruments ...
Lead Quality Assurance resource needed to provide quality support for global computer validation projects in the ERP area, such as SAP, under the guidance of the Global Quality Computer Compliance ...
Lead Quality Assurance resource needed to provide quality support for global computer validation projects in the ERP area, such as SAP, under the guidance of the Global Quality Computer Compliance ...
Raritan, NJ ยท On-site
$48 - $53/hr
Experience in the Pharmaceutical, biotechnology, or medical device industry. * 2+ years' experience with System Development Lifecycle. * 3+ years' experience in Computer System Validation.
New
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Raritan, NJ ยท On-site
$48 - $53/hr
Experience in the Pharmaceutical, biotechnology, or medical device industry. * 2+ years' experience with System Development Lifecycle. * 3+ years' experience in Computer System Validation.
New
Somerville, NJ ยท On-site
$72K - $116K/yr
Bachelor's degree in Engineering, Computer Science, Science, or related discipline. * Knowledge of validation lifecycle approach and FDA/international regulatory requirements. * Ability to work with ...
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Somerville, NJ ยท On-site
$72K - $116K/yr
Bachelor's degree in Engineering, Computer Science, Science, or related discipline. * Knowledge of validation lifecycle approach and FDA/international regulatory requirements. * Ability to work with ...
Raritan, NJ ยท On-site
$48 - $53/hr
Experience in the Pharmaceutical, biotechnology, or medical device industry. * 2+ years experience with System Development Lifecycle. * 3+ years experience in Computer System Validation. * Experience ...
Raritan, NJ ยท On-site
$48 - $53/hr
Experience in the Pharmaceutical, biotechnology, or medical device industry. * 2+ years experience with System Development Lifecycle. * 3+ years experience in Computer System Validation. * Experience ...
Computer validation experience is required. PLC (programmable logic controller) experience required. Knowledge and application of advanced analytics tools in manufacturing is preferred. Knowledge of ...
Computer validation experience is required. PLC (programmable logic controller) experience required. Knowledge and application of advanced analytics tools in manufacturing is preferred. Knowledge of ...
Lakewood, NJ ยท On-site
$77K - $95K/yr
Update and manage the Validation Master List within the central computer system * Support client audits and new project discussions as a representative of the Validation and Quality teams
Lakewood, NJ ยท On-site
$77K - $95K/yr
Update and manage the Validation Master List within the central computer system * Support client audits and new project discussions as a representative of the Validation and Quality teams
Validation Specialist Lynkx Staffing LLC specializes in placing talented professionals in the ... Good computer skills and Microsoft Office knowledge. * Ability to multi-task team is essential.
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Validation Specialist Lynkx Staffing LLC specializes in placing talented professionals in the ... Good computer skills and Microsoft Office knowledge. * Ability to multi-task team is essential.
Princeton, NJ ยท On-site
$140K - $152K/yr
Bachelor's or Master's degree in Engineering, Science, Medical, or a related field. * 6 - 10 years of hands-on experience in Computer System Validation within GxP-regulated environments (GCP/GMP; FDA ...
Princeton, NJ ยท On-site
$140K - $152K/yr
Bachelor's or Master's degree in Engineering, Science, Medical, or a related field. * 6 - 10 years of hands-on experience in Computer System Validation within GxP-regulated environments (GCP/GMP; FDA ...
Validation Engineer WhoYou'llWork With You will join one of our 45 offices in the US, bepart of a ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
Validation Engineer WhoYou'llWork With You will join one of our 45 offices in the US, bepart of a ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
East Brunswick, NJ ยท On-site
Validation Engineer Who You'll Work With You will join one of our 45 offices in the US, be part of ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
East Brunswick, NJ ยท On-site
Validation Engineer Who You'll Work With You will join one of our 45 offices in the US, be part of ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
Validation Engineer WhoYou'llWork With You will join one of our 45 offices in the US, bepart of a ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
Validation Engineer WhoYou'llWork With You will join one of our 45 offices in the US, bepart of a ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
Hightstown, NJ ยท On-site
Manages the full lifecycle of Computer System Validation, qualifying facilities, equipment, and processes, and developing key validation documentation, including Factory Acceptance Testing, Site ...
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Hightstown, NJ ยท On-site
Manages the full lifecycle of Computer System Validation, qualifying facilities, equipment, and processes, and developing key validation documentation, including Factory Acceptance Testing, Site ...
East Windsor, NJ ยท On-site
Manages the full lifecycle of Computer System Validation, qualifying facilities, equipment, and processes, and developing key validation documentation, including Factory Acceptance Testing, Site ...
East Windsor, NJ ยท On-site
Manages the full lifecycle of Computer System Validation, qualifying facilities, equipment, and processes, and developing key validation documentation, including Factory Acceptance Testing, Site ...
Strong computer skills are also required * Willing and able to travel as necessary for project ... As a Sr. Validation Engineer, you will build a meaningful and fulfilling career with the support of ...
Strong computer skills are also required * Willing and able to travel as necessary for project ... As a Sr. Validation Engineer, you will build a meaningful and fulfilling career with the support of ...
$10.74 - $17.70
2% of jobs
$17.70 - $24.67
9% of jobs
$24.67 - $31.64
1% of jobs
$31.64 - $38.60
4% of jobs
$42.83 is the 25th percentile. Wages below this are outliers.
$38.60 - $45.57
15% of jobs
$45.57 - $52.54
9% of jobs
The median wage is $58.34 / hr.
$52.54 - $59.50
13% of jobs
$65.05 is the 75th percentile. Wages above this are outliers.
$59.50 - $66.47
29% of jobs
$66.47 - $73.44
12% of jobs
$73.44 - $80.40
2% of jobs
$80.40 - $87.37
5% of jobs
$10
$55
$87
| Aspect | Computer Validation | Quality Assurance Specialist |
|---|---|---|
| Required Credentials | GxP, 21 CFR Part 11, validation certifications | ISO standards, QA certifications, GxP knowledge |
| Work Environment | Pharmaceutical, biotech, regulated industries | Manufacturing, healthcare, regulated industries |
| Employer & Industry Usage | Regulated industries requiring validated systems | Ensuring quality compliance across processes |
Computer Validation focuses on verifying that computer systems meet regulatory requirements and function correctly, primarily in regulated industries. Quality Assurance Specialists oversee overall quality processes, ensuring compliance and standards across various operations. While both roles require knowledge of GxP and industry regulations, Computer Validation is more technical and system-specific, whereas QA Specialists have a broader scope in quality management.
Other
Posted 4 days ago
Role: Validation Lead(Computer System Validation โ GenAI, Agentic QMS)
Location: Raritan, NJ(Hybrid)
Duration: 12 Months
Job Description:
โข Experience in the Pharmaceutical, biotechnology, or medical device industry
โข 2+ yearsโ experience with System Development Lifecyle
โข 3+ yearsโ experience in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
โข Knowledge of FDA guidanceโs and industry standards (i.e., GAMP)
โข Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
โข Experience in QA Methodologies, designing, reviewing, and approving User Stories, Test Plans and Reports, System and UAT test scripts, Test procedures, Traceability Matrix, and Design Specs.
โข Strong verbal and written communication skills.
โข Ability to lead a team. Ability to work with remote teams and support several changes/projects simultaneously.
โข Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
โข Ability to work with global project teams during the initial project planning phases
โข Ability to provide guidance on validation strategy and be able to handle the highly fluid state of the project
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1 - 10 Employees
Dallas, TX, US
1998