- Regeneron Pharmaceuticals (Troy, NY)
- … Specialist would also plan, coordinate and participate in compliant computer system validation (CSV) process for systems which require formal validation ... We are hiring a Principal QA Validation Specialist to support validation and...certain background checks will form part of the recruitment process . Background checks will be conducted in accordance with… more
- Lilly (Pleasant Prairie, WI)
- …previous facility or area start up experience + Has previous qualification and validation experience ( process automation and/or IT systems) + Has previous Six ... and integrity principles in operational processes, and Computer System Validation methodologies to ensure regulatory compliance, consistency, and sustainment. The… more
- Teleflex (Maple Grove, MN)
- …* Train and direct technicians in performing equipment qualifications, process characterization, test method validation execution, failure investigations. ... Sr. Principal Engineer, Verification & Validation , R&D **Date:** Dec 19, 2025 **Location:** Maple...characterization to allow selection of optimal design concepts and process technology. * Design the structure of flows of… more
- Kelly Services (Anasco, PR)
- …computer and automation systems that do not perform as intended during validation runs. Recommend process /quality improvements as part of validation ... and trainings necessary for the engineering team. Actively participate in the Validation Life Cycle of regulated projects by reviewing validation documentation,… more
- BD (Becton, Dickinson and Company) (Sumter, SC)
- …and Key Process Output Variables (KPOVs). + Responsible for execution of process verification, process validation and production ramp-up activities for ... equipment validation , and vertical start-up into the existing manufacturing process ensuring the training plan and competence assessments are completed. 4 Ensure… more
- Amgen (Thousand Oaks, CA)
- …Validation and Process Control** + Assist in developing and executing process validation protocols and reports. + Collect, analyze, and interpret ... + Experience in aseptic Drug Product or biologics manufacturing + Knowledge of process validation , deviation management, and change control + Strong analytical… more
- ThermoFisher Scientific (Wilmington, NC)
- … validation strategies are science- and risk-based, in accordance with FDA Process Validation Guidance, Annex 15, and ICH principles, supporting PSG's ... & Cleaning Validation Leadership + Develop and review process validation protocols and reports, ensuring compliance and sound scientific rationale for APIs,… more
- Mentor Technical Group (Juncos, PR)
- …validation tools (eg, AutoCAD, TrackWise, Veeva). Preferred Skills: + CQV, Process Validation , or Project Management certifications. + Experience with ... related field. + Minimum 3-5 years of experience in commissioning, qualification, and validation of biotech process equipment (both upstream and downstream). +… more
- PCI Pharma Services (Rockford, IL)
- …be responsible for planning, developing, implementing and monitoring the equipment and process validation strategy for PCI's Advanced Drug Delivery business. The ... a successful design/tech transfer with NPI by directly supporting or driving validation processes with appropriate risk management leadership. As the new product is… more
- VTI Life Sciences (Los Angeles, CA)
- …+ Equipment Installation Qualification, Operational Qualification and Performance Qualification + Process Validation + Equipment Cleaning Validation + ... validation of critical facility systems + Software Validation including data management and process control...+ Software Validation including data management and process control systems. + Compile Validation Reports… more