- Fujifilm (College Station, TX)
- … Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems , engineering design ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- Lilly (Pleasant Prairie, WI)
- …management expertise to solve problems both locally and across global M&Q. Act as the Computer systems validation quality assurance project lead, working ... of experience in Computer System Quality Assurance/ Computer System Validation...and project management experience + Demonstrated proficiency with GMP computer systems validation including regulations… more
- Kedrion Biopharma (Melville, NY)
- …automation and computer systems within a GMP production facility. Computer System Validation Specialist is responsible for managing, developing, and ... hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Computer System Validation Specialist at...Validation Life Cycle + Perform all aspects of Quality Systems Management processes such as … more
- PCI Pharma Services (Bedford, NH)
- …and guidelines (eg FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or Pharmaceutical ... with departments inside the organization to maintain and improve computer system validation processes to...skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems… 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
- 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
- Abeona (Cleveland, OH)
- Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... production. Essential Duties and Responsibilities . Develop and execute validation deliverables for new and existing GxP systems...trial management systems (eg, CTMS, EDC) . Quality systems (eg, QMS, Document Management … 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
- Cognizant (Muskegon, MI)
- …engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The ... MES, ABB as well as other DCS and OT systems . **Requirements** : The Validation Lead responsibilities...project guidelines Quality review of project documentation Quality review of testing documentation Review of validation… more
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