- Danaher Corporation (Chaska, MN)
- …Knowledge of FDA regulations, ISO standards, and GxP guidelines. + Experience with Computer System Validation (CSV) and process validation It would be a ... System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior QA Validation Engineer is responsible for assisting in the sustainment… more
- Capgemini (Fort Washington, PA)
- …(formerly Korber PAS-X) with knowledge of Control Systems and experience with Validation process. You will ensure compliance with industry standards and regulations ... with industry regulations, including GMPs (Good Manufacturing Practices) and FDA guidelines. + Documentation: Maintain comprehensive documentation of automation… more
- Medtronic (Villalba, PR)
- …position offers a unique opportunity to contribute to meaningful projects, including computer system validation , process validation , data analysis, ... experience or PhD with 0 years relevant experience. **Nice to Have (Preferred** ): ** Computer System Validation ** + Proficient in executing Computer System … more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... and process development and improvement, implementation of product/process verification, validation activities, and commercialization. Responsibilities for this role also… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Jarratt, VA)
- …reviews and approves proposals, risk assessments, baseline data, preventive controls, validation data, and assesses steps in dependence on product/process being ... the results associated with Sanitation KPI's, Internal & External Inspections (USDA, FDA , GFSI) and Customers Requirements. It is responsible for identifying food… more
- Caris Life Sciences (Irving, TX)
- …Supports the authoring and reviewing of pre-defined deliverables as identified in the Computer System Validation Process and applicable Software Validation ... internal SOPs, Quality System Requirements which include ISO 13485, FDA QSR, IVDR, SOX, SOC2, and IEC 62304 +...lead auditor to ensure the supplier's software development and validation practices comply with Caris's Computer System… more
- Endo International (Rochester, MI)
- …of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and ... for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist...and Good Manufacturing Practices (GMP) + Ensure compliance with FDA and other regulatory standards + Follow safety procedures… more
- BeOne Medicines (Pennington, NJ)
- …and release of material, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... Biochemistry laboratory routine operations, including but not limited to validation , SOP revisions, specification updates, testing records, personnel training and,… more
- West Pharmaceutical Services (Walker, MI)
- …approval of resolutions. + Keep current with all Industry standard practices and FDA requirements for validation , change control and complaint handling. + ... through our sustainability efforts. **Job Summary** + Provide support for the validation program for the plant or assigned functional area regarding equipment,… more
- Terumo Neuro (Aliso Viejo, CA)
- …quality assurance projects and activities to meet the sterilization validation requirements of medical products. Lead sterilization process commissioning, initial ... sterilization validation and re- validation activities. Provide technical support...Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO. + Support clean room monitoring and… more