- Abbott (Lake Forest, IL)
- …ISO13485, 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
- Kedrion Biopharma (Melville, NY)
- …the CSV guidelines and procedures. **ESSENTIAL JOB FUNCTIONS** The Computer Systems Validation Specialist is responsible for implementing FDA 21 CFR Part 11 ... standards and current industry practices. The focus of the Computer Validation Specialist role is to identify...History and Audit Trail + Conduct Data Integrity Assessments, FDA 21CFR Part11 and EU GMP Annex11 assessments +… 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
- 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
- Abeona (Cleveland, OH)
- Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... laboratory, manufacturing, quality) are validated and maintained in compliance with FDA , EMA, and other global regulatory standards. This role involves close… 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
- Catalent Pharma Solutions (Harmans, MD)
- …Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation , USP Guidelines, ICH Guidelines, and ISPE GAMP guidelines. ... **Associate Director, Validation & Engineering** Catalent Pharma Solutions is looking...of life-enhancing and life-saving treatments for patients annually. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is… more
- J&J Family of Companies (Wilson, NC)
- … Computer system Validation in a cGMP pharmaceutical facility working with FDA regulations + Experience in Computer system Validation working with ... of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data… more
- Novo Nordisk (Bloomington, IN)
- …and approve deviations relevant to equipment validation + Understand other validation technical disciplines, such as cleaning, computer system validation ... and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry...other validation technical disciplines, such as equipment validation , computer system validation , and… more
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