Computer System Validation (CSV) Engineer Locations: Piscataway, NJ | Chicago, IL Work Arrangement: Onsite Employment Type: Full-Time Experience: 5+ Years of CSV Experience in a GxP-Regulated ...
Computer System Validation (CSV) Engineer Locations: Piscataway, NJ | Chicago, IL Work Arrangement: Onsite Employment Type: Full-Time Experience: 5+ Years of CSV Experience in a GxP-Regulated ...
Job Title:- Computer System Validation (CSV) Consultants Location:- Piscataway, NJ/Chicago, IL (Onsite) Duration:- Contract to hire Responsibilities * Plan, author, execute, and maintain CSV ...
Job Title:- Computer System Validation (CSV) Consultants Location:- Piscataway, NJ/Chicago, IL (Onsite) Duration:- Contract to hire Responsibilities * Plan, author, execute, and maintain CSV ...
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 ...
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 ...
IT Validation Specialist
Somerset, NJ · Hybrid
Execute and support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems. * Author and maintain validation documentation, including:
New
IT Validation Specialist
Somerset, NJ · Hybrid
Execute and support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems. * Author and maintain validation documentation, including:
New
IT Validation Specialist
Somerset, NJ · On-site
Execute and support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems. * Author and maintain validation documentation, including:
New
IT Validation Specialist
Somerset, NJ · On-site
Execute and support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems. * Author and maintain validation documentation, including:
New
... Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and enterprise supply chain applications; strong knowledge of CSA ...
... Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and enterprise supply chain applications; strong knowledge of CSA ...
Validation Lead
Raritan, NJ · On-site
$50 - $55/hr
Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and separation contexts. * Experience in writing and executing documentation for all aspects of ...
Quick apply
Validation Lead
Raritan, NJ · On-site
$50 - $55/hr
Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and separation contexts. * Experience in writing and executing documentation for all aspects 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 ...
Computer validation experience is required. PLC (programmable logic controller) experience required. Knowledge and application of advanced analytics tools in manufacturing is preferred. Knowledge of ...
Validation Lead
Raritan, NJ · On-site
Raritan, NJ(Hybrid) Duration: 6+ Months Must Have - Computer System Validation Experience M&A related Data Migration and related infrastructure qualification in data Platform domain * Must be able to ...
Validation Lead
Raritan, NJ · On-site
Raritan, NJ(Hybrid) Duration: 6+ Months Must Have - Computer System Validation Experience M&A related Data Migration and related infrastructure qualification in data Platform domain * Must be able to ...
Validation Engineer
New York, NY · On-site
$70K - $80K/yr
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field (or equivalent practical experience). * Strong attention to detail and ability to manage multiple validation ...
Validation Engineer
New York, NY · On-site
$70K - $80K/yr
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field (or equivalent practical experience). * Strong attention to detail and ability to manage multiple validation ...
Validation Engineer
East Brunswick, NJ · 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
East Brunswick, NJ · 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 ...
Validation Engineer
East Brunswick, NJ · On-site
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
East Brunswick, NJ · On-site
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 II
East Windsor, NJ · 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 ...
Quick apply
Validation Engineer II
East Windsor, NJ · 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 ...
CSV/Validation Consultant
Raritan, NJ · On-site
... Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and enterprise supply chain applications; strong knowledge of CSA ...
CSV/Validation Consultant
Raritan, NJ · On-site
... Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and enterprise supply chain applications; strong knowledge of CSA ...
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 ...
Validation Engineer II
Branchburg, NJ · On-site
$75K/yr
Preferred Bachelor's degree in engineering , science or computer science is Highly Desired. 3+ years validation experience writing and executing ( IQ/OQ/PQ ) with systems and equipment on the shop ...
Validation Engineer II
Branchburg, NJ · On-site
$75K/yr
Preferred Bachelor's degree in engineering , science or computer science is Highly Desired. 3+ years validation experience writing and executing ( IQ/OQ/PQ ) with systems and equipment on the shop ...
Computer Validation information
See Bridgewater, NJ salary details
$10.81 - $17.83
2% of jobs
$17.83 - $24.84
9% of jobs
$24.84 - $31.86
1% of jobs
$31.86 - $38.87
4% of jobs
$43.13 is the 25th percentile. Wages below this are outliers.
$38.87 - $45.88
15% of jobs
$45.88 - $52.90
9% of jobs
The median wage is $58.74 / hr.
$52.90 - $59.91
13% of jobs
$65.50 is the 75th percentile. Wages above this are outliers.
$59.91 - $66.93
29% of jobs
$66.93 - $73.94
12% of jobs
$73.94 - $80.96
2% of jobs
$80.96 - $87.97
5% of jobs
$10
$55
$87
How much do computer validation jobs pay per hour?
What is the difference between Computer Validation vs Quality Assurance Specialist?
| 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.
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Posted 4 days ago
Job description
Title : Computer System Validation (CSV) Engineer
Locations: Piscataway, NJ | Chicago, IL
Work Arrangement: Onsite
Employment Type: Full-Time
Experience: 5+ Years of CSV Experience in a GxP-Regulated Environment
We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, manufacturing and engineering equipment, and enterprise applications.
The CSV Engineer will work closely with Quality, IT, Laboratory, and Manufacturing teams to ensure computerized systems remain validated and compliant with GxP, 21 CFR Part 11, EU Annex 11, and applicable EMA requirements.
This is an onsite position reporting to the Sr. Director of IT. The successful candidate will have strong hands-on experience developing and executing CSV deliverables within a regulated life sciences environment.
Key Responsibilities- Plan, author, review, and execute CSV deliverables, including:
- Validation Plans
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- Design Specifications (DS)
- IQ/OQ/PQ protocols
- Traceability Matrices
- Validation Summary Reports (VSR)
- Perform CSV activities for:
- Laboratory instruments such as HPLC, spectrophotometers, and balances
- Engineering and manufacturing equipment
- LIMS platforms
- SAP systems
- CMMS/calibration systems such as BMRAM
- Partner with System Owners, QA, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state.
- Support change control, periodic reviews, and validation lifecycle activities.
- Conduct computerized system risk assessments and data integrity assessments in alignment with ALCOA+ principles.
- Support audits, regulatory inspections, CAPA investigations, deviations, and compliance activities related to computerized systems.
- Collaborate with senior validation leads and subject matter experts to establish and maintain consistent CSV practices across sites.
- Ensure validation documentation meets applicable regulatory and quality standards.
- Bachelor's degree in Life Sciences, Engineering, Information Technology, or a related field, or equivalent laboratory experience within a life sciences environment.
- Minimum 5 years of Computer System Validation (CSV) experience in a GxP-regulated environment.
- Strong working knowledge of:
- 21 CFR Part 11
- EU Annex 11
- EMA guidance
- GxP compliance requirements
- Hands-on experience authoring and executing IQ/OQ/PQ protocols.
- Familiarity with GAMP 5 principles.
- Experience with risk-based validation methodologies.
- Exposure to Caliber LIMS.
- Experience with SAP QM, MM, or PP in a GxP environment.
- Experience with BMRAM or comparable CMMS/calibration systems.
- Experience working as a liaison between IT, Quality, Laboratory, and Manufacturing teams.
- Strong understanding of computerized system lifecycle management and data integrity principles.