They are seeking a Software Test Method Validation (TMV) engineer to develop and maintain ... Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving ...
They are seeking a Software Test Method Validation (TMV) engineer to develop and maintain ... Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Overview We are seeking an experienced Analytical Chemist to support analytical testing, method validation, and ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Overview We are seeking an experienced Analytical Chemist to support analytical testing, method validation, and ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Overview We are seeking an experienced Analytical Chemist to support analytical testing, method validation, and ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Overview We are seeking an experienced Analytical Chemist to support analytical testing, method validation, and ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Overview We are seeking an experienced Analytical Chemist to support analytical testing, method validation, and ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Overview We are seeking an experienced Analytical Chemist to support analytical testing, method validation, and ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Hours: 40.0 ... Execute and support analytical method validation activities, primarily focused on Gas ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Hours: 40.0 ... Execute and support analytical method validation activities, primarily focused on Gas ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Overview We are seeking an experienced Analytical Chemist to support analytical testing, method validation, and ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Overview We are seeking an experienced Analytical Chemist to support analytical testing, method validation, and ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Overview We are seeking an experienced Analytical Chemist to support analytical testing, method validation, and ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Overview We are seeking an experienced Analytical Chemist to support analytical testing, method validation, and ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Hours: 40.0 ... Execute and support analytical method validation activities, primarily focused on Gas ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Hours: 40.0 ... Execute and support analytical method validation activities, primarily focused on Gas ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Hours: 40.0 ... Execute and support analytical method validation activities, primarily focused on Gas ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Hours: 40.0 ... Execute and support analytical method validation activities, primarily focused on Gas ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Overview We are seeking an experienced Analytical Chemist to support analytical testing, method validation, and ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Contract Compensation: $45 - $48 per hour pending overall experience Work Model: Onsite Overview We are seeking an experienced Analytical Chemist to support analytical testing, method validation, and ...
Scientist
South Plainfield, NJ · On-site
... contract) Job Summary * Scientist II reports to and takes direction from the Associate Director, R&D. * Scientist II is knowledgeable in the areas of method development, method validation, and drug ...
Scientist
South Plainfield, NJ · On-site
... contract) Job Summary * Scientist II reports to and takes direction from the Associate Director, R&D. * Scientist II is knowledgeable in the areas of method development, method validation, and drug ...
Sr. Specialist, Data Review - R&D
Cherry Hill, NJ · On-site
$67 - $134/hr
Knowledge in pharmaceutical cGMP requirements, ICH/US FDA guidelines, Laboratory test procedures, raw material analyses, method validation guidelines, analytical method transfers, finished products ...
Sr. Specialist, Data Review - R&D
Cherry Hill, NJ · On-site
$67 - $134/hr
Knowledge in pharmaceutical cGMP requirements, ICH/US FDA guidelines, Laboratory test procedures, raw material analyses, method validation guidelines, analytical method transfers, finished products ...
Senior Scientist, Analytical Testing
$109K - $132K/yr
The scientist performs analytical method validation and cGMP activities and provides oversight and ... contract laboratories & service providers. Operates within and maintains the laboratory in an ...
Senior Scientist, Analytical Testing
$109K - $132K/yr
The scientist performs analytical method validation and cGMP activities and provides oversight and ... contract laboratories & service providers. Operates within and maintains the laboratory in an ...
Senior Scientist, Analytical Testing
New Brunswick, NJ · On-site
$109 - $132/hr
The scientist performs analytical method validation and cGMP activities and provides oversight and ... acquired by contract laboratories & service providers. * Operates within and maintains the ...
New
Senior Scientist, Analytical Testing
New Brunswick, NJ · On-site
$109 - $132/hr
The scientist performs analytical method validation and cGMP activities and provides oversight and ... acquired by contract laboratories & service providers. * Operates within and maintains the ...
New
Senior Scientist, Analytical Testing
New Brunswick, NJ · On-site
$109K - $132K/yr
The scientist performs analytical method validation and cGMP activities and provides oversight and ... acquired by contract laboratories & service providers. * Operates within and maintains the ...
Senior Scientist, Analytical Testing
New Brunswick, NJ · On-site
$109K - $132K/yr
The scientist performs analytical method validation and cGMP activities and provides oversight and ... acquired by contract laboratories & service providers. * Operates within and maintains the ...
Senior Scientist, Analytical Testing
New Brunswick, NJ · On-site
$109K - $132K/yr
The scientist performs analytical method validation and cGMP activities and provides oversight and ... acquired by contract laboratories & service providers. * Operates within and maintains the ...
Senior Scientist, Analytical Testing
New Brunswick, NJ · On-site
$109K - $132K/yr
The scientist performs analytical method validation and cGMP activities and provides oversight and ... acquired by contract laboratories & service providers. * Operates within and maintains the ...
Senior Scientist, Analytical Testing
New Brunswick, NJ · On-site
$109 - $132/hr
The scientist performs analytical method validation and cGMP activities and provides oversight and ... acquired by contract laboratories & service providers. * Operates within and maintains the ...
New
Senior Scientist, Analytical Testing
New Brunswick, NJ · On-site
$109 - $132/hr
The scientist performs analytical method validation and cGMP activities and provides oversight and ... acquired by contract laboratories & service providers. * Operates within and maintains the ...
New
Validation Engineer III
Piscataway, NJ · On-site
$70K - $90K/yr
Additionally, interface with Contract Manufacturers to ensure all relevant user and functional ... analysis methodologies (5-Whys, Ishikawa, Fault Tree). * Prepare, Review and approve vendor ...
Validation Engineer III
Piscataway, NJ · On-site
$70K - $90K/yr
Additionally, interface with Contract Manufacturers to ensure all relevant user and functional ... analysis methodologies (5-Whys, Ishikawa, Fault Tree). * Prepare, Review and approve vendor ...
$21.50 - $25/hr
Determines best methods of procurement (i.e. contract purchase order, NAF Purchase Card, etc ... Ensures buys meet all requirements and regulations for valid NAF Purchase card purchases and obtain ...
$21.50 - $25/hr
Determines best methods of procurement (i.e. contract purchase order, NAF Purchase Card, etc ... Ensures buys meet all requirements and regulations for valid NAF Purchase card purchases and obtain ...
Validation Engineer III
Piscataway, NJ · On-site
$70K - $90K/yr
Additionally, interface with Contract Manufacturers to ensure all relevant user and functional ... analysis methodologies (5-Whys, Ishikawa, Fault Tree). * Prepare, Review and approve vendor ...
Validation Engineer III
Piscataway, NJ · On-site
$70K - $90K/yr
Additionally, interface with Contract Manufacturers to ensure all relevant user and functional ... analysis methodologies (5-Whys, Ishikawa, Fault Tree). * Prepare, Review and approve vendor ...
Contract Method Validation information
What is the difference between Contract Method Validation vs Analytical Method Validation?
| Aspect | Contract Method Validation | Analytical Method Validation |
|---|---|---|
| Purpose | Validates that a contracted method meets specific requirements for a particular project or client | Ensures an analytical method is accurate, reliable, and reproducible for testing purposes |
| Scope | Typically project-specific, focusing on methods used under contractual agreements | Broader, covering method development, validation, and routine testing |
| Credentials | Often requires validation expertise, GMP knowledge, and industry-specific certifications | Requires analytical chemistry knowledge, validation experience, and relevant certifications |
| Work Environment | Pharmaceutical, biotech, or manufacturing settings with client-specific projects | Laboratories performing routine testing and method development in similar industries |
Contract Method Validation focuses on validating methods for specific client projects, while Analytical Method Validation ensures the overall reliability of testing methods used routinely in laboratories. Both roles require similar credentials and work in related environments, but their scope and purpose differ.
What cities in New Jersey are hiring for Contract Method Validation jobs?
Cities in New Jersey with the most Contract Method Validation job openings:
Full-time
Re-posted 27 days ago
Job description
Job Summary:
Katalyst CRO is a company focused on software and systems verification for FDA-regulated medical devices. They are seeking a Software Test Method Validation (TMV) engineer to develop and maintain verification protocols, perform various levels of testing, and ensure compliance with industry regulations.
Responsibilities:
• Develop, execute, and maintain software/system verification protocols and test strategies for FDA-regulated medical devices.
• Perform functional, integration, regression, and system-level testing for embedded software and firmware applications.
• Validate safety-critical workflows including alarms, dosage calculations, thermal control systems, and patient safety features.
• Execute risk-based testing aligned with FMEA and ISO 14971 requirements.
• Design and maintain automated GUI and regression frameworks using Squish, Selenium, Python, and Pytest.
• Integrate automated test suites with Jenkins/GitLab CI pipelines for continuous validation and release readiness.
• Improve test coverage, execution efficiency, and defect detection rates through automation initiatives.
• Perform Hardware-in-the-Loop (HIL) testing using LabVIEW, TCUs, and embedded communication interfaces.
• Validate embedded communication protocols including TCP/IP, Ethernet, UART, and serial communication.
• Use oscilloscopes, multimeters, flow meters, and J-Link debuggers for hardware/software integration testing.
• Create and maintain test cases, protocols, traceability matrices (RTM), verification reports, and defect documentation.
• Ensure compliance with IEC 62304, ISO 13485, IEC 60601/61010, IEC 62366, FDA 21 CFR Part 11, and QMS standards.
• Support FDA audits, 510(k) submissions, CAPA investigations, and post-market remediation activities.
• Participate in Agile/Scrum ceremonies and cross-functional collaboration with firmware, hardware, systems, and QA teams.
• Lead defect triage, root-cause analysis, and corrective/preventive action verification.
• Support change control and release validation activities for medical device software products.
Qualifications:
Required:
• Software V&V for medical devices and embedded systems
• Test Automation: Squish, Selenium, Python, Pytest
• CI/CD Tools: Jenkins, GitLab CI, Azure DevOps, Bitbucket
• ALM & Traceability Tools: Jama Connect, IBM DOORS, Polarion ALM, Helix ALM
• Embedded interfaces: UART, TCP/IP, Ethernet, serial communication
• HIL testing, LabVIEW, J-Link debugger
• SQL, HTML, CSS
Company:
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. Founded in , the company is headquartered in South Plainfield, USA, with a team of 51-200 employees. The company is currently Growth Stage.
Katalyst CRO is a company focused on software and systems verification for FDA-regulated medical devices. They are seeking a Software Test Method Validation (TMV) engineer to develop and maintain verification protocols, perform various levels of testing, and ensure compliance with industry regulations.
Responsibilities:
• Develop, execute, and maintain software/system verification protocols and test strategies for FDA-regulated medical devices.
• Perform functional, integration, regression, and system-level testing for embedded software and firmware applications.
• Validate safety-critical workflows including alarms, dosage calculations, thermal control systems, and patient safety features.
• Execute risk-based testing aligned with FMEA and ISO 14971 requirements.
• Design and maintain automated GUI and regression frameworks using Squish, Selenium, Python, and Pytest.
• Integrate automated test suites with Jenkins/GitLab CI pipelines for continuous validation and release readiness.
• Improve test coverage, execution efficiency, and defect detection rates through automation initiatives.
• Perform Hardware-in-the-Loop (HIL) testing using LabVIEW, TCUs, and embedded communication interfaces.
• Validate embedded communication protocols including TCP/IP, Ethernet, UART, and serial communication.
• Use oscilloscopes, multimeters, flow meters, and J-Link debuggers for hardware/software integration testing.
• Create and maintain test cases, protocols, traceability matrices (RTM), verification reports, and defect documentation.
• Ensure compliance with IEC 62304, ISO 13485, IEC 60601/61010, IEC 62366, FDA 21 CFR Part 11, and QMS standards.
• Support FDA audits, 510(k) submissions, CAPA investigations, and post-market remediation activities.
• Participate in Agile/Scrum ceremonies and cross-functional collaboration with firmware, hardware, systems, and QA teams.
• Lead defect triage, root-cause analysis, and corrective/preventive action verification.
• Support change control and release validation activities for medical device software products.
Qualifications:
Required:
• Software V&V for medical devices and embedded systems
• Test Automation: Squish, Selenium, Python, Pytest
• CI/CD Tools: Jenkins, GitLab CI, Azure DevOps, Bitbucket
• ALM & Traceability Tools: Jama Connect, IBM DOORS, Polarion ALM, Helix ALM
• Embedded interfaces: UART, TCP/IP, Ethernet, serial communication
• HIL testing, LabVIEW, J-Link debugger
• SQL, HTML, CSS
Company:
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. Founded in , the company is headquartered in South Plainfield, USA, with a team of 51-200 employees. The company is currently Growth Stage.