- Beckman Coulter Diagnostics (Miami, FL)
- …of FDA regulations, ISO standards, and GxP guidelines.Experience with Computer System Validation (CSV) and process validationIt would be a ... tools that address the world's biggest health challenges. The Senior QA Validation Engineer for Beckman Coulter Diagnostics is responsible for assisting in the… more
- Butterball (Garner, NC)
- …experience related to the design and execution of challenge studies, validation studies, etc.. Excellent written and verbal communication, interpersonal, and ... skills. Thorough understanding of food safety regulations (eg, USDA, FDA , HACCP, GFSI, FSMA). Familiarity with poultry food production...kneel, and use hands and fingers to operate a computer , telephone, keyboard, and occasionally lift up to 50… more
- Abbott (Lake Forest, IL)
- …ISO13495, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer ... Specialist** **Key Responsibilities also include:** + Effectively assess regulatory and validation requirements for computer systems within organization +… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Bristol Myers Squibb (Devens, MA)
- …more: careers.bms.com/working-with-us . **Summary:** We are seeking a highly skilled and motivated Computer System Validation (CSV) Engineer to join our team at ... + Stay current with industry trends and regulatory updates related to computer system validation . **Qualifications:** + Bachelor's degree in Computer… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... is hiring a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
- Boehringer Ingelheim (St. Joseph, MO)
- …of validation of biopharmaceutical processes, equipment, utilities, facilities, cleaning validation , and USDA and FDA /EU regulations. + * Excellence in ... comprehension/application of USDA and FDA /EU regulatory requirements for validation /qualification of equipment/process/cleaning...detail. + * This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for… more
- Fujifilm (College Station, TX)
- …preferably in FDA -regulated environment. + Associate of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 7+ years of ... experience in pharmaceutical, biotechnology, or related industry, preferably in FDA -regulated environment, OR; + Bachelor's Degree and 5+ years...experience in computer system validation activities in pharmaceutical, biotechnology,… more
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