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.
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.
Overview The Scientist, Analytical Method Development for Radiopharmaceuticals, is responsible for the development, optimization, validation, and transfer of analytical methods supporting ...
Overview The Scientist, Analytical Method Development for Radiopharmaceuticals, is responsible for the development, optimization, validation, and transfer of analytical methods supporting ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Quick apply
Analytical Chemist
Lakewood, NJ · On-site
$45 - $48/hr
Support analytical testing, method validation, and method transfer activities within a laboratory environment. * Execute and support analytical method validation activities, primarily focused on Gas ...
Author and execute method qualification, validation, and verification protocols in accordance with ICH and regulatory expectations * Lead or support analytical method transfer to internal QC ...
Author and execute method qualification, validation, and verification protocols in accordance with ICH and regulatory expectations * Lead or support analytical method transfer to internal QC ...
Overview The Scientist, Analytical Method Development for Radiopharmaceuticals, is responsible for the development, optimization, validation, and transfer of analytical methods supporting ...
Overview The Scientist, Analytical Method Development for Radiopharmaceuticals, is responsible for the development, optimization, validation, and transfer of analytical methods supporting ...
Detailed Complete method validation for global rapid microbiology test method, supporting upgrade of Celsis reagents from current enzyme to AmpiScreen. Record & Document results. Provide support for ...
Detailed Complete method validation for global rapid microbiology test method, supporting upgrade of Celsis reagents from current enzyme to AmpiScreen. Record & Document results. Provide support for ...
The Associate Director of Analytical Development and CMC Statistics will provide technical and statistical leadership for analytical development, method validation, method transfer, comparability ...
The Associate Director of Analytical Development and CMC Statistics will provide technical and statistical leadership for analytical development, method validation, method transfer, comparability ...
AR&D Scientist I/II
Monmouth Junction, NJ · On-site
... or method validation in the pharmaceutical or biotechnology industry OR Masters degree in Chemistry or related science field and minimum 0-3 years experience in analytical/method development or ...
AR&D Scientist I/II
Monmouth Junction, NJ · On-site
... or method validation in the pharmaceutical or biotechnology industry OR Masters degree in Chemistry or related science field and minimum 0-3 years experience in analytical/method development or ...
Scientist
South Plainfield, NJ · On-site
Develop and validate methods for experimental drug candidates. * Perform characterization studies for impurities, degradants, intermediates, and active components of drug substances and drug products.
Scientist
South Plainfield, NJ · On-site
Develop and validate methods for experimental drug candidates. * Perform characterization studies for impurities, degradants, intermediates, and active components of drug substances and drug products.
Essential functions of the position include the following: o Develop and validate methods for experimental drug candidates o Perform characterization studies for impurities, degradants, intermediates ...
Essential functions of the position include the following: o Develop and validate methods for experimental drug candidates o Perform characterization studies for impurities, degradants, intermediates ...
Provide scientific and technical leadership for analytical method development, qualification, validation, transfer, troubleshooting, and lifecycle management for biologic drug substance and drug ...
Provide scientific and technical leadership for analytical method development, qualification, validation, transfer, troubleshooting, and lifecycle management for biologic drug substance and drug ...
Senior Scientist, R&D - Assay Development
South Plainfield, NJ · On-site
$125K - $140K/yr
Perform method validation experiments including precision, accuracy, linearity, interference, and stability testing per established protocols * Apply Design of Experiments (DOE) and statistical ...
Senior Scientist, R&D - Assay Development
South Plainfield, NJ · On-site
$125K - $140K/yr
Perform method validation experiments including precision, accuracy, linearity, interference, and stability testing per established protocols * Apply Design of Experiments (DOE) and statistical ...
Senior Scientist, R&D - Assay Development
South Plainfield, NJ · On-site
$120 - $180/hr
Perform method validation experiments including precision, accuracy, linearity, interference, and stability testing per established protocols * Apply Design of Experiments (DOE) and statistical ...
Senior Scientist, R&D - Assay Development
South Plainfield, NJ · On-site
$120 - $180/hr
Perform method validation experiments including precision, accuracy, linearity, interference, and stability testing per established protocols * Apply Design of Experiments (DOE) and statistical ...
QA Associate
East Windsor, NJ · On-site
Review and approve Master documents such as Master Batch Records, In-process forms, Method Qualification Protocols, Method Validation Protocols, test methods, reference standards and other related ...
QA Associate
East Windsor, NJ · On-site
Review and approve Master documents such as Master Batch Records, In-process forms, Method Qualification Protocols, Method Validation Protocols, test methods, reference standards and other related ...
Method Validation information
See New Jersey salary details
$22.94 - $28.07
2% of jobs
$28.07 - $33.19
6% of jobs
$33.19 - $38.32
13% of jobs
$39.92 is the 25th percentile. Wages below this are outliers.
$38.32 - $43.44
13% of jobs
$43.44 - $48.57
11% of jobs
The median wage is $51.13 / hr.
$48.57 - $53.69
12% of jobs
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9% of jobs
$62.77 is the 75th percentile. Wages above this are outliers.
$58.82 - $63.94
13% of jobs
$63.94 - $69.07
13% of jobs
$69.07 - $74.19
6% of jobs
$74.19 - $79.32
3% of jobs
$22
$52
$79
How much do method validation jobs pay per hour?
What is a method validation?
A Method Validation job involves assessing and verifying analytical methods to ensure they produce reliable, accurate, and reproducible results. Professionals in this role typically work in pharmaceutical, biotechnology, or chemical industries, following regulatory guidelines such as ICH, USP, or FDA requirements. Their responsibilities include designing validation protocols, performing experiments, analyzing data, and documenting results. Method validation ensures compliance with industry standards and guarantees product quality and safety.
What does a method validation do?
As a Method Validation professional, you will design, conduct, and document experiments to confirm that laboratory methods produce accurate and reproducible results under specified conditions. Typical daily tasks include preparing protocols, running validation samples, analyzing data, and preparing comprehensive validation reports for internal or regulatory review. You’ll work closely with scientists, quality assurance teams, and regulatory specialists to ensure compliance with industry standards. This collaborative environment provides opportunities to contribute to critical product development stages and to build expertise that supports career progression into quality management, regulatory affairs, or advanced analytical roles.
What are the key skills and qualifications needed for method validation?
To excel in Method Validation, a strong background in analytical chemistry, laboratory techniques, and scientific data analysis is typically required, often supported by a degree in chemistry, biochemistry, or a related field. Familiarity with validation protocols, industry regulations (such as GLP, GMP, or ISO standards), and analytical instrumentation (e.g., HPLC, GC, MS) is essential. Strong attention to detail, problem-solving skills, and effective collaboration and documentation abilities help professionals thrive in this position. These skills are vital to ensure that laboratory methods are reliable, regulatory-compliant, and suitable for their intended purposes.
What are the most commonly searched types of Method Validation jobs in New Jersey?
The most popular types of Method Validation jobs in New Jersey are:
What are popular job titles related to Method Validation jobs in New Jersey?
For Method Validation jobs in New Jersey, the most frequently searched job titles are:
What job categories do people searching Method Validation jobs in New Jersey look for?
The top searched job categories for Method Validation jobs in New Jersey are:

Software Test Method Validation (TMV)
South Plainfield, NJ • On-site
Full-time
Re-posted 19 days ago
Job description
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.