- Abbott (Lake Forest, IL)
- …in ISO13485, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA ... **Key Responsibilities also include:** + Effectively assess regulatory and validation requirements for computer systems ... within organization + Identify and develop all required computer system validation deliverables including… more
- Cordis (Irvine, CA)
- …implement practical business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation ... (PLM). You'll map business processes end-to-end, translate them into system requirements, and lead continuous improvement initiatives that boost productivity,… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who...In depth understanding and knowledge of successfully validating a computer system to meet all FDA ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... involved in processing steps related to equipment, facility/utility and computer systems validation . This role...to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE… more
- J&J Family of Companies (Raritan, NJ)
- …Responsibilities:** + Provide preparation, generation and flawless execution of Computer System Validation for GMP Systems and Processes. + Collaborate ... searching for the best talent for a Sr. Engineer, Computer System Validation (CSV) to...managing Validation activities, with a focus on computer systems , software, as well as GMP… more
- Abeona (Cleveland, OH)
- Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... through commercial production. Essential Duties and Responsibilities . Develop and execute validation deliverables for new and existing GxP systems in alignment… 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 ... regulatory and performance standards. **What You'll Do:** + Lead validation activities throughout the computer system...assessments, and execute validation protocols for GxP systems and infrastructure. + Ensure compliance with FDA… 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 ... / assist in the preparation of clear and concise validation deliverables for computerized systems , including ...related field. + _Experience:_ 1-3 years of experience in computer system validation within a… more
- Kedrion Biopharma (Melville, NY)
- …audit trails, access controls, data migration, and backup._ + _Own and maintain system validation procedures and documentation across the site._ + _Partner with ... opportunity to make a real impact by shaping our validation program in alignment with FDA , EU,...GAMP 5 standards._ **_Job Role and Responsibilities_** + _Lead validation projects for GxP systems -authoring and executing… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part… more