- Catalent Pharma Solutions (Kansas City, MO)
- …is hiring a **Quality Engineer II, Validation ** . The Quality Engineer II, Validation provides review and approval of all Computer System Validation and ... include QA oversight of equipment design, equipment qualification, process validation , cleaning validation , computer system...are engineering sound and in compliance with all + FDA QSR/cGMP, ISO, and Quality Policies of the company… more
- Cognizant (Boston, MA)
- … to guarantee seamless integration across platforms. + Coordinate Computer System Validation (CSV) activities to ensure alignment with FDA , EMA, MHRA, and ... **About the role** As a ** Validation & Testing Lead in Life Sciences** ,..., you will make an impact by driving the validation and testing strategy for Document Management Systems (DMS)… more
- 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
- dsm-firmenich (Exton, PA)
- … program that aligns with global regulation requirements, defining procedures for computer system validation and assurance, and drive decisions around the ... **Senior Expert, Software Validation and Cybersecurity** **Exton, PA** The role will...and subject matter expert for software compliance related to computer systems assurance as defined by global regulatory requirements,… more
- Genentech (Oceanside, CA)
- …automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The ... you will have responsibilities for IT OT compliance and Validation ensure compliance for all IT Systems. As part...Represent ITOT in internal(SSI, GARA, quality etc.) and external audits( FDA etc.). + "Right to Operate" : Manage ITOT… more
- ThermoFisher Scientific (New Brunswick, NJ)
- …This information may include roadmap/obsolesce data, risk/issue lists, feature requests. + Apply FDA CFR 251 Part 11/EU Annex 11 GAMP 5, and other applicable global ... health authority regulations to the lifecycle of computer systems to ensure they are in a validated state, supporting regulated business processes and computer … more
- Amgen (Thousand Oaks, CA)
- …+ Broad working knowledge of key IS domains and layers + Understanding of FDA regulations governing computer system validation and operation + Familiarity ... with security requirements and best practices for data at rest and in transit + Success in mentoring and developing strong product analysts, business analysts, and developers + Experience in FMCG/CPG/Retail/Manufacturing industry **Professional… 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
- Fujifilm (College Station, TX)
- …of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data ... knowledge of engineering principles. + Working knowledge and expertise in computerized systems validation . + Computer System Validation experience with DCS,… 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