Design, develop, validate and execute test methods to inform design decisions and verify system ... SolidWorks or CAD proficiency for mechanical fixture design * Experience coding data acquisition ...
Design, develop, validate and execute test methods to inform design decisions and verify system ... SolidWorks or CAD proficiency for mechanical fixture design * Experience coding data acquisition ...
Computer Systems Validation * Manage the organization's Computer Systems Validation (CSV) strategy, governance framework and establish risk-based approaches for validation of GxP computerized systems.
Computer Systems Validation * Manage the organization's Computer Systems Validation (CSV) strategy, governance framework and establish risk-based approaches for validation of GxP computerized systems.
Computer Systems Validation * Manage the organization's Computer Systems Validation (CSV) strategy, governance framework and establish risk-based approaches for validation of GxP computerized systems.
Computer Systems Validation * Manage the organization's Computer Systems Validation (CSV) strategy, governance framework and establish risk-based approaches for validation of GxP computerized systems.
Computer Systems Validation * Manage the organization's Computer Systems Validation (CSV) strategy, governance framework and establish risk-based approaches for validation of GxP computerized systems.
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Computer Systems Validation * Manage the organization's Computer Systems Validation (CSV) strategy, governance framework and establish risk-based approaches for validation of GxP computerized systems.
Senior CSV Validation Engineer
Lexington, MA · On-site
$115K - $140K/yr
A minimum of a bachelor's degree in Engineering, Computer Science or related discipline ON-THE-JOB EXPERIENCE * 7+ years of Computer System Validation experience * Strong understanding of GxP ...
Senior CSV Validation Engineer
Lexington, MA · On-site
$115K - $140K/yr
A minimum of a bachelor's degree in Engineering, Computer Science or related discipline ON-THE-JOB EXPERIENCE * 7+ years of Computer System Validation experience * Strong understanding of GxP ...
A minimum of a bachelor's degree in Engineering, Computer Science or related discipline ON-THE-JOB EXPERIENCE * 7+ years of Computer System Validation experience * Strong understanding of GxP ...
A minimum of a bachelor's degree in Engineering, Computer Science or related discipline ON-THE-JOB EXPERIENCE * 7+ years of Computer System Validation experience * Strong understanding of GxP ...
A minimum of a bachelor's degree in Engineering, Computer Science or related discipline ON-THE-JOB EXPERIENCE * 7+ years of Computer System Validation experience * Strong understanding of GxP ...
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A minimum of a bachelor's degree in Engineering, Computer Science or related discipline ON-THE-JOB EXPERIENCE * 7+ years of Computer System Validation experience * Strong understanding of GxP ...
Program Manager - AI Transformation in Life Sciences Testing & Validation
Boston, MA · On-site
$116K - $183K/yr
Deep expertise in Computer System Validation (CSV) , Computer Software Assurance (CSA), GxP regulations, FDA and EMA requirements, 21 CFR Part 11, and GAMP 5. Proven experience leading large-scale ...
Program Manager - AI Transformation in Life Sciences Testing & Validation
Boston, MA · On-site
$116K - $183K/yr
Deep expertise in Computer System Validation (CSV) , Computer Software Assurance (CSA), GxP regulations, FDA and EMA requirements, 21 CFR Part 11, and GAMP 5. Proven experience leading large-scale ...
Undergraduate degree in Computer Science, Data Science, Artificial Intelligence, Applied ... Lead end-to-end validation of AI, GenAI, and Agentic AI solutions, from initial review of ...
Undergraduate degree in Computer Science, Data Science, Artificial Intelligence, Applied ... Lead end-to-end validation of AI, GenAI, and Agentic AI solutions, from initial review of ...
IT System and Validation Analyst
Watertown, MA · On-site
$125 - $150/hr
Previous experience in Computer System Validation (CSV) within an FDA-regulated or GxP environment. * Strong working knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11 with the ability to apply ...
New
IT System and Validation Analyst
Watertown, MA · On-site
$125 - $150/hr
Previous experience in Computer System Validation (CSV) within an FDA-regulated or GxP environment. * Strong working knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11 with the ability to apply ...
New
Previous experience in Computer System Validation (CSV) within an FDA-regulated or GxP environment. * Strong working knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11 with the ability to apply ...
Previous experience in Computer System Validation (CSV) within an FDA-regulated or GxP environment. * Strong working knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11 with the ability to apply ...
Undergraduate degree in Computer Science, Data Science, Artificial Intelligence, Applied ... and validation. * Experience with Agentic AI frameworks such as LangChain, LangGraph, AutoGen ...
Undergraduate degree in Computer Science, Data Science, Artificial Intelligence, Applied ... and validation. * Experience with Agentic AI frameworks such as LangChain, LangGraph, AutoGen ...
Finance; Computer Science, Management Information Systems, or Statistics/Mathematics. * 4+ years of experience within the Financial Crime industry. * 4+ years of model validation, AML system ...
Finance; Computer Science, Management Information Systems, or Statistics/Mathematics. * 4+ years of experience within the Financial Crime industry. * 4+ years of model validation, AML system ...
System Test and Validation Lead
Boston, MA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Boston, MA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
IT System and Validation Analyst
Northbridge, MA · On-site
$125 - $150/hr
Align internal CSV processes with GAMP 5, 21 CFR Part 11, EU Annex 11, and FDA Computer Software ... Validation Plans; URS/FS; risk assessments; traceability matrices; IQ/OQ/PQ protocols and test ...
New
IT System and Validation Analyst
Northbridge, MA · On-site
$125 - $150/hr
Align internal CSV processes with GAMP 5, 21 CFR Part 11, EU Annex 11, and FDA Computer Software ... Validation Plans; URS/FS; risk assessments; traceability matrices; IQ/OQ/PQ protocols and test ...
New
System Test and Validation Lead
Boston, MA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Boston, MA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Boston, MA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Boston, MA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Computer Vision / Machine Learning Engineer
Boston, MA · On-site
$100 - $125/hr
Train, validate, and deploy computer vision models, with an emphasis on instance segmentation * Tracking & Fusion: Implement tracking approaches that combine color and depth data to maintain object ...
Computer Vision / Machine Learning Engineer
Boston, MA · On-site
$100 - $125/hr
Train, validate, and deploy computer vision models, with an emphasis on instance segmentation * Tracking & Fusion: Implement tracking approaches that combine color and depth data to maintain object ...
Software Tool Verification and Validation Engineer Location: Newton, MA Job Summary We are seeking ... Qualifications Education Bachelor's degree in Computer Science, Software Engineering, Biomedical ...
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Software Tool Verification and Validation Engineer Location: Newton, MA Job Summary We are seeking ... Qualifications Education Bachelor's degree in Computer Science, Software Engineering, Biomedical ...
Computer Field Technician
Needham, MA · On-site
$35/hr
You must have a reliable form of transportation and a valid driver's license to run these calls. You will be visiting multiple work sites throughout your day. * You must have access to a computer and ...
Computer Field Technician
Needham, MA · On-site
$35/hr
You must have a reliable form of transportation and a valid driver's license to run these calls. You will be visiting multiple work sites throughout your day. * You must have access to a computer and ...
Computer Validation information
See Marlborough, MA salary details
$10.97 - $18.09
2% of jobs
$18.09 - $25.21
9% of jobs
$25.21 - $32.32
1% of jobs
$32.32 - $39.44
4% of jobs
$43.76 is the 25th percentile. Wages below this are outliers.
$39.44 - $46.56
15% of jobs
$46.56 - $53.67
9% of jobs
The median wage is $59.61 / hr.
$53.67 - $60.79
13% of jobs
$66.46 is the 75th percentile. Wages above this are outliers.
$60.79 - $67.91
29% of jobs
$67.91 - $75.03
12% of jobs
$75.03 - $82.14
2% of jobs
$82.14 - $89.26
5% of jobs
$10
$56
$89
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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Full-time
Re-posted 18 days ago
IPG Photonics rating
8.2
Based on 18 frontline employees who took The Breakroom Quiz
137th of 499 rated machine equipment manufacturers
Job description
Our mission is to develop innovative laser solutions to make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged and thriving workforce that drives a sustainable future for our company and society.
Working at IPG Photonics you can expect challenging projects, a motivating and friendly environment, and competitive benefits.
Position Summary
The Test Engineer designs, builds, and validates test methods for verification and validation testing for medical devices and disposables in an ISO 13485 and FDA QSR compliant environment. This Role reports to Quality Management, supporting various project teams in different stages of project maturity from R&D through Production.
Key Responsibilities
- Verification Testing: Plan and execute Design Verification and Validation activities for com plex electromechanical devices and single-use disposables
- Test Method Development: Design, develop, validate and execute test methods to inform design decisions and verify system functionality
- Research & Development: Conduct early-stage exploratory testing and characterization to support design inputs
- Equipment Development: Design, fabricate, and assemble custom test fixtures and automated equipment
- Equipment Validation: Write and execute protocols and reports for test software and hardware
- Documentation: Author test protocols, data sheets, and final reports. Author/assist manufacturing procedures, machine instructions
- Quality Compliance: Ensure all activities align with ISO 13485, FDA 21 CFR Part 820, and risk management standards
- Data Analysis: Apply statistical techniques like ANOVA, Gage R&R, and capability analysis to test datasets
- Communication: Present test findings to relevant stakeholders, communicate risk and countermeasure insights as applicable
- Required Qualifications
- Education: Bachelor's degree in Mechanical, Electrical, Biomedical, or Quality Engineering, or 3-4 additional years of trade experience
- Experience: 2-5 years of engineering experience within the medical device or regulated industry
- Regulations: Working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards
- Verification & Validation: Direct experience in planning and execution of Verification and Validation for complex electrotechnical devices
- Validation Skills: Direct experience writing and executing Equipment IQ/OQ/PQ and Test Method Validation (TMV)
- Technical Tools: Proficiency with data acquisition systems, and proficiency in analysis tools like MATLAB, or statistical software like Minitab
- Lab Skills: Hands-on experience using mechanical test equipment like tensile testers, gauges, and sensors
Preferred Qualifications
- Experience with endoscopic surgical laser systems
- Experience with surgical fluid irrigation/aspiration systems and components (pumps, pressure sensors, flow sensors)
- Experience testing polymer-based fluid delivery components or single-use medical disposables (biocompatibility, sterilization validation)
- SolidWorks or CAD proficiency for mechanical fixture design
- Experience coding data acquisition using Python / C, able to troubleshoot basic code
- Able to read schematics
- Experience with rapid prototyping (SLA, FDM, CNC)
What IPG Photonics employees say
Pay
Benefits
Hours and flexibility
Workplace
Get the full story on Breakroom
About IPG Photonics
Sourced by ZipRecruiter
Industry
Electrical equipment, appliance, and component manufacturing
Company size
1,001 - 5,000 Employees
Headquarters location
Oxford, MA, US
Year founded
1990