Analytical Test Method Validation Engineer - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Develop, validate, and implement analytical test methods for combination products in compliance with regulatory standards and internal quality requirements.
Collaborate cross-functionally with device engineers, laboratory teams, and quality departments to ensure alignment and successful execution of test method validation (TMV) activities.
Provide expert guidance on analytical strategies for device-related products, ensuring robust and reproducible methods are established.
Evaluate and optimize existing test methods for accuracy, precision, and reliability.
Document and report findings, ensuring compliance with regulatory standards and company policies.
Support regulatory submissions by preparing validation protocols, reports, and related documentation.
Troubleshoot and resolve analytical issues during method development and validation phases.
Qualifications
A minimum of 8+ years of experience in analytical testing, method validation, or related roles within the pharmaceutical and/or combination medical device industry.
Strong expertise in test method validation (TMV) for medical devices and combination products.
Hands-on experience with a variety of device-related products such as auto-injectors, prefilled syringes, oral dose formulations, and nasal sprays.
Previous experience with nasal spray product testing and validation is highly desirable.
Comprehensive knowledge of FDA, ISO, and other applicable regulatory standards for pharmaceutical and medical devices.
Exceptional communication skills with the ability to collaborate effectively across teams, including engineers, laboratory staff, and quality professionals.
Strong analytical and problem-solving skills with attention to detail.
Proficient in preparing technical documentation and validation reports.
Preferred Skills
Experience with advanced analytical instrumentation and techniques.
Familiarity with combination product regulatory requirements and lifecycle management.
Collaborate cross-functionally with device engineers, laboratory teams, and quality departments to ensure alignment and successful execution of test method validation (TMV) activities.
Provide expert guidance on analytical strategies for device-related products, ensuring robust and reproducible methods are established.
Evaluate and optimize existing test methods for accuracy, precision, and reliability.
Document and report findings, ensuring compliance with regulatory standards and company policies.
Support regulatory submissions by preparing validation protocols, reports, and related documentation.
Troubleshoot and resolve analytical issues during method development and validation phases.
Qualifications
A minimum of 8+ years of experience in analytical testing, method validation, or related roles within the pharmaceutical and/or combination medical device industry.
Strong expertise in test method validation (TMV) for medical devices and combination products.
Hands-on experience with a variety of device-related products such as auto-injectors, prefilled syringes, oral dose formulations, and nasal sprays.
Previous experience with nasal spray product testing and validation is highly desirable.
Comprehensive knowledge of FDA, ISO, and other applicable regulatory standards for pharmaceutical and medical devices.
Exceptional communication skills with the ability to collaborate effectively across teams, including engineers, laboratory staff, and quality professionals.
Strong analytical and problem-solving skills with attention to detail.
Proficient in preparing technical documentation and validation reports.
Preferred Skills
Experience with advanced analytical instrumentation and techniques.
Familiarity with combination product regulatory requirements and lifecycle management.
Source : Katalyst Healthcares & Life Sciences