- 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
- Cordis (Irvine, CA)
- …implement practical business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation ... user stories, and test scripts; proficient with SQL for data validation . + Excellent facilitation, communication, and stakeholder-management skills. + Motivated to… 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
- 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
- Charles River Laboratories (Wayne, PA)
- …protocols]. + Write or assist in the writing of SOPs as they pertain to computer system validation and data integrity. + Collaborate with cross functional teams ... related field. + _Experience:_ 1-3 years of experience in computer system validation within a regulated industry...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- PCI Pharma Services (Bedford, NH)
- …team. In this role, you'll take the lead in developing and executing validation strategies for GxP computer systems-ensuring everything from equipment to ... highest regulatory and performance standards. **What You'll Do:** + Lead validation activities throughout the computer system lifecycle-including plans,… more
- J&J Family of Companies (Raritan, NJ)
- …We are searching for the best talent for a Sr. Engineer, Computer System Validation (CSV) to join our Team **!** Janssen ... Engineer - CSV is responsible for performing and managing Validation activities, with a focus on computer ...for Pharmaceutical Engineering (ISPE) guidelines such as GAMP 5, FDA Data Integrity guidelines, 21 Code of Federal Regulations… 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
- Kedrion Biopharma (Melville, NY)
- …portfolio._ _This is an exciting opportunity to make a real impact by shaping our validation program in alignment with FDA , EU, and GAMP 5 standards._ **_Job ... _Kedrion is looking for a_ **_Validation Specialist - Computer Systems_** _to join our team and play...As a Subject Matter Expert (SME), you will lead validation efforts and support the development, commercialization, and lifecycle… more
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