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.
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 ...
Senior Validation Engineer (I, II, III)
Bridgewater, NJ · On-site
$90K - $210K/yr
Knowledge of CSV methodology and required lifecycle document content including risk-based approaches used to validate technical systems * Knowledge of Data Integrity and ALCOA+ principles and the ...
Senior Validation Engineer (I, II, III)
Bridgewater, NJ · On-site
$90K - $210K/yr
Knowledge of CSV methodology and required lifecycle document content including risk-based approaches used to validate technical systems * Knowledge of Data Integrity and ALCOA+ principles and the ...
Senior Validation Engineer (I, II, III)
Bridgewater, NJ · On-site
$90K - $210K/yr
Knowledge of CSV methodology and required lifecycle document content including risk-based approaches used to validate technical systems * Knowledge of Data Integrity and ALCOA+ principles and the ...
Senior Validation Engineer (I, II, III)
Bridgewater, NJ · On-site
$90K - $210K/yr
Knowledge of CSV methodology and required lifecycle document content including risk-based approaches used to validate technical systems * Knowledge of Data Integrity and ALCOA+ principles and the ...
Senior Validation Engineer (I, II, III)
Bridgewater, NJ · On-site
$90K - $210K/yr
Knowledge of CSV methodology and required lifecycle document content including risk-based approaches used to validate technical systems * Knowledge of Data Integrity and ALCOA+ principles and the ...
Quick apply
Senior Validation Engineer (I, II, III)
Bridgewater, NJ · On-site
$90K - $210K/yr
Knowledge of CSV methodology and required lifecycle document content including risk-based approaches used to validate technical systems * Knowledge of Data Integrity and ALCOA+ principles and the ...
Develop and validate methods for experimental drug candidates. * Perform characterization studies for impurities, degradants, intermediates, and active components of drug substances and drug products.
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 ...
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 ...
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 ...
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 Manager
Harrison, NJ · On-site
Responsible for preparation and review of Protocol and report of Analytical Method validation, method transfer and Verification * Responsible to support to Computer system validation of Quality ...
QA Manager
Harrison, NJ · On-site
Responsible for preparation and review of Protocol and report of Analytical Method validation, method transfer and Verification * Responsible to support to Computer system validation of Quality ...
Validation Lead
Raritan, NJ · On-site
Role - Validation Lead Location -Raritan, NJ(Hybrid) Job Details: 5+ years of Computer System ... Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test ...
Validation Lead
Raritan, NJ · On-site
Role - Validation Lead Location -Raritan, NJ(Hybrid) Job Details: 5+ years of Computer System ... Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test ...
Validation Lead
Raritan, NJ · On-site
Role - Validation Lead Location - Raritan, NJ (Hybrid) W2/C2C Job Details: 5+ years of Computer ... Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test ...
Validation Lead
Raritan, NJ · On-site
Role - Validation Lead Location - Raritan, NJ (Hybrid) W2/C2C Job Details: 5+ years of Computer ... Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test ...
Analytical Science Manager
Parsippany, NJ · On-site
$100K - $135K/yr
Lead analytical method transfers and validation activities for drug substance and drug products. * Author and review GMP documents such as SOPs, protocols, summary reports, and QMS records. * Partner ...
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Analytical Science Manager
Parsippany, NJ · On-site
$100K - $135K/yr
Lead analytical method transfers and validation activities for drug substance and drug products. * Author and review GMP documents such as SOPs, protocols, summary reports, and QMS records. * Partner ...
Validation Lead
Raritan, NJ · On-site
$48 - $53/hr
... Validation Reports ... Experience in QA Methodologies, designing, reviewing and approving User Stories, Test Plans and ...
Quick apply
Validation Lead
Raritan, NJ · On-site
$48 - $53/hr
... Validation Reports ... Experience in QA Methodologies, designing, reviewing and approving User Stories, Test Plans and ...
Analytical Science Manager
Parsippany, NJ · On-site
$100K - $135K/yr
Lead analytical method transfers and validation activities for drug substance and drug products. * Author and review GMP documents such as SOPs, protocols, summary reports, and QMS records. * Partner ...
Quick apply
Analytical Science Manager
Parsippany, NJ · On-site
$100K - $135K/yr
Lead analytical method transfers and validation activities for drug substance and drug products. * Author and review GMP documents such as SOPs, protocols, summary reports, and QMS records. * Partner ...
Analytical Science Manager
Parsippany, NJ · On-site
$100K - $135K/yr
Lead analytical method transfers and validation activities for drug substance and drug products. * Author and review GMP documents such as SOPs, protocols, summary reports, and QMS records. * Partner ...
Analytical Science Manager
Parsippany, NJ · On-site
$100K - $135K/yr
Lead analytical method transfers and validation activities for drug substance and drug products. * Author and review GMP documents such as SOPs, protocols, summary reports, and QMS records. * Partner ...
Validation Engineer
Fairfield, NJ · On-site
$100K - $110K/yr
We're currently seeking a passionate and skilled Validation Engineer to join our team and ... Knowledge of quality inspection tools and methods required. Familiarity with Statistical Process ...
Validation Engineer
Fairfield, NJ · On-site
$100K - $110K/yr
We're currently seeking a passionate and skilled Validation Engineer to join our team and ... Knowledge of quality inspection tools and methods required. Familiarity with Statistical Process ...
Support transfer of commercial methods and method validation in compliance with global regulatory requirements. Responsible for the stewardship of bioassay, flow cytometry and/or molecular methods in ...
Support transfer of commercial methods and method validation in compliance with global regulatory requirements. Responsible for the stewardship of bioassay, flow cytometry and/or molecular methods in ...
Scientist, Mass Spec & Characterization, Biosimilars ARD
$35.25 - $44.25/hr
Ensure adherence to highest quality and efficiency standards in laboratory operations (cGLP, cGMP) Develop, optimize, and validate new chromatography methods using literature references and ...
Scientist, Mass Spec & Characterization, Biosimilars ARD
$35.25 - $44.25/hr
Ensure adherence to highest quality and efficiency standards in laboratory operations (cGLP, cGMP) Develop, optimize, and validate new chromatography methods using literature references and ...
Validation Engineer
Fairfield, NJ · Hybrid
$100K - $110K/yr
We're currently seeking a passionate and skilled Validation Engineer to join our team and ... Knowledge of quality inspection tools and methods required. Familiarity with Statistical Process ...
Validation Engineer
Fairfield, NJ · Hybrid
$100K - $110K/yr
We're currently seeking a passionate and skilled Validation Engineer to join our team and ... Knowledge of quality inspection tools and methods required. Familiarity with Statistical Process ...
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
$53.69 - $58.82
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 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 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.

Full-time
Re-posted 2 hours 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.