- Beckman Coulter Diagnostics (Miami, FL)
- …of FDA regulations, ISO standards, and GxP guidelines.Experience with Computer System Validation (CSV) and process validationIt would ... 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
- Abbott (Lake Forest, IL)
- …in ISO13495, 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
- 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
- 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
- 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
- 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
- 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
- Boehringer Ingelheim (St. Joseph, MO)
- …staff and other departments. + Leads and actively supports strategic direction of validation philosophies, improve overall validation system and process flow ... effort and is responsible for assuring compliance of validated systems , process, equipment to current cGMP, FDA ,...(VMP) and Corporate Policies and Procedures. + Maintains site validation database and document systems , supports feasibility… more
- J&J Family of Companies (Wilson, NC)
- …of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with ... Coordinates and executes training of required personnel on the computer and automation systems validation ...working with FDA regulations + Experience in Computer system Validation working with… more
- Fujifilm (College Station, TX)
- …Life Sciences, Engineering, or similar discipline with 7+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or ... Plans (VPPs), System Impact Assessment (SIAs) and drafting and executing validation protocols for Facilities, Utilities, Systems and Equipment (FUSE), as… more
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