Job Details. Roles & Responsibilities. Develop and execute validation strategies. Lead Process Validation & PPQ activities. Perform C&Q for equipment, utilities, and facility systems. Run risk and gap assessments. Maintain equipment master data and support change controls. Execute floor-level validation in GMP cleanrooms. Coordinate sampling and data collection. Support recipe authoring, data trending, and automation needs. Train and guide cross-...
Job Details. Responsibilities. The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This role is key to implementing programming standards and supporting the standardization of CDISC-compliant datasets (e.g., SDTM, ADaM) across clinical programs. Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures...
Job Details. Job Description. We are seeking an experienced Method Validation Engineer to support the development, validation, and implementation of analytical methods-primarily dissolution and particulate matter testing (USP. )-for a GMP release testing laboratory supporting a pharmaceutical compounding facility. The consultant will work alongside an existing chemist trained in UPLC analysis to ensure methods meet regulatory, quality, and operat...
Job Details. Summary. We are seeking a talented Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes and systems. You will be responsible for designing, implementing, and executing validation protocols to ensure that equipment, facilities, and processes meet regulatory requirements and industry standards. Roles & Responsibilities. Design ...
Job Details. Summary. We are seeking a talented Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes and systems. You will be responsible for designing, implementing, and executing validation protocols to ensure that equipment, facilities, and processes meet regulatory requirements and industry standards. Roles & Responsibilities. Design ...
Job Details. Job Summary. We are seeking an experienced and highly skilled Lead Validation Engineer to support validation, quality, engineering, and manufacturing programs within a cGMP-regulated biopharmaceutical environment. The ideal candidate brings deep expertise in cleaning validation, equipment qualification, CQV, tech transfer support, and quality systems, along with the ability to lead cross-functional teams through complex validation an...
Job Details. Job Summary. We are seeking an experienced and highly skilled Lead Validation Engineer to support validation, quality, engineering, and manufacturing programs within a cGMP-regulated biopharmaceutical environment. The ideal candidate brings deep expertise in cleaning validation, equipment qualification, CQV, tech transfer support, and quality systems, along with the ability to lead cross-functional teams through complex validation an...
Job Details. Job Description. We are seeking a Product Development Tech for our Brea, CA facility. This person contributes to the completion of routine technical tasks and develops solutions to routine technical problems of specified scope. Their contacts are primarily with immediate supervisor, project leaders, and other professionals in the unit. Responsibilities. Gathers, maintains, formats, compiles, and manipulates technical data, such as la...
Job Details. Job Description. We are seeking a Product Development Tech for our Brea, CA facility. This person contributes to the completion of routine technical tasks and develops solutions to routine technical problems of specified scope. Their contacts are primarily with immediate supervisor, project leaders, and other professionals in the unit. Responsibilities. Gathers, maintains, formats, compiles, and manipulates technical data, such as la...
Job Details. Responsibilities. Working with the Architect and PO, you will develop requirements documentation. Working with the various (development, QA, DevOps) teams, you will develop design documentation. Working with DevOps and cyber-security, you will provide oversight for the development and QA processes. Working with QA, you will review the developed features & enhancements against the requirements for conformance. Requirements. 4 years as...
Job Details. Job Summary. A leading organization is seeking an experienced Validation Engineer to support validation strategy, compliance, and qualification activities for digital solutions in a GMP-regulated environment. Roles and Responsibilities. Develop and implement validation strategies aligned with regulatory and internal standards. Create validation plans and protocols for digital solutions, data pipelines, models, and automation tools. P...
Job Details. Summary. Supports testing and validation activities for medical devices, ensuring compliance with regulatory and quality standards. Roles & Responsibilities. Prepare test samples and fixtures for mechanical and functional testing. Execute tests and document results per Good Documentation Practices (GDP).Generate Test Reports for inclusion in the Design History File (DHF). Coordinate with cross-functional teams to ensure timely comple...
