- 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
- 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
- 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
- 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
- Curia (Rensselaer, NY)
- …team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems ... functional areas across the organization to maintain and improve computer system validation processes to...experience working in a cGMP regulated industry specific to computer systems validation + … more