- Beckman Coulter Diagnostics (Miami, FL)
- …methodologies.Knowledge of FDA regulations, ISO standards, and GxP guidelines.Experience with Computer System Validation (CSV) and process validationIt ... 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 ... Outlook, Teams, SharePoint, etc.), Power BI, enterprise resource planning (ERP) systems such as SAP, and quality management systemsPreferred Knowledge, Skills, and… 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
- 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 ... system change controls, deviations, and CAPAs related to computer systems . + Provide training and guidance...current with industry trends and regulatory updates related to computer system validation . **Qualifications:** +… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and ... 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
- Boehringer Ingelheim (Ridgefield, CT)
- …Approach depending on process and technical risks Proactive and consultative engagement of the Computer System Validation role within agile projects 2. Guide ... framework by conducting self-developed, process adapted training. Give active feedback into the Computer System Validation (CSV, Management System Owner… more
- PCI Pharma Services (Bedford, NH)
- …/software/equipment. Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, ... skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems...(eg FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation … more
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... and commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT… more
- Lilly (Indianapolis, IN)
- …ingredients (API) and parenteral manufacturing for future injectable therapies (Drug Product). The Computer System Validation Engineer is an Engineering role ... Automation & Control Engineering team (GPACE). It will support Computer System Validation and Data...agility and experience in one or more process automation systems with a strong focus on data, systems… more
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