- University of Washington (Seattle, WA)
- …The Department of Laboratory Medicine and Pathology has an outstanding opportunity for a ** Computer Systems GxP Validation Specialist** **WORK SCHEDULE** ... manufacture, and distribution. + Maintain an inventory of GxP computer systems , assess validation status, and prioritize actions based on risk.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Specific experience with Veeva Vault products and reporting is a plus + GxP computer systems and validation experience + Knowledge of Quality Systems ... product families, materials, planned and manufactured batches/lots, suppliers/vendors, assets ( computer systems , instruments, equipment), clinical trials, etc.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … validation or qualification of global GxP and Non- GxP computer systems .Create and review various validation documentation such as Validation ... **Responsibilities** - Provide Validation Lead support for Daiichi Sankyo GxP and Non- GxP computer systems implementations in partnership with Global… more
- Clarkston Consulting (Philadelphia, PA)
- …that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant, and in this role, you will deliver ... knowledge, and consulting excellence. What You'll Do As a Computer Systems Validation (CSV) Consultant...systems in pharmaceutical, biotech, medical device, and other GxP and GAMP regulated environments + Perform as a… more
- Bristol Myers Squibb (Bothell, WA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The Computer Systems Validation (CSV) Sr.Engineer works cross-functionally to ... lead and execute validation activities for GxP electronic ...reviews and audit activities as well as support of computer system validation efforts for new system… more
- Amgen (West Greenwich, RI)
- …work alongside other innovative, driven professionals in this meaningful role. **Specialist Computer Systems Validation Engineer** **Live** **What you will ... lead with business and DTI partners for process and computer systems analysis, requirements elicitation, articulating system... GxP and SOX compliance requirements + Lead computer validation testing initiates with oversight of… more
- Charles River Laboratories (Memphis, TN)
- Computer Validation Engineer II Req ID...or related discipline * 5-7 years' experience in a GxP environment working with facility, utilities, systems , ... timelines and milesstones using appropriate tools * Develop and implement solutions to validation issues * Present validation systems program during internal… more
- Charles River Laboratories (Wayne, PA)
- Computer Systems Validation Specialist...5-7 years related experience in Computer System Validation . Prior experience working in a GxP ... all times. * Write and assist in writing all validation deliverables within the Computer System Lifecycle,...using appropriate tools. * Develop and implement solutions to validation issues. * Present validation systems… more
- Novo Nordisk (West Lebanon, NH)
- …Senior CSV Analyst (Remote) position is to provide subject matter expertise in Computer Systems Validation , process improvement, and IT compliance service ... lives of people with chronic diseases. Essential Functions + Computer Systems Validation Expert: +...SME participating in Audits and Inspections. + Experience on GxP , change management and deviation handling. + Experience with… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies to patients worldwide. Join Takeda as a Senior Manager, Cell Therapy Systems and Validation where you will enable implementation of new equipment, ... coordinate with cross functional groups (IT, QA, Manufacturing, Process Development etc.) to validate GXP equipment and systems . You will serve as site lead for … more
- Insight Global (West Chester, PA)
- …and delivery with benefits delivered as committed required. * Experience in GxP systems , Computer System Validation , and consistent track record in the ... engineers to design, develop, configure and test MES (Manufacturing Execution Systems ) solutions. They will be direct responsibility of leading resources contracted… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …for manufacturing use. + Provides technical support and guidance on equipment and computer system qualification and validation issues. + Participates in ... validation of software systems in collaboration with IT, validation , QA...(URS, DQ, IQ, OQ, PQ, etc.) + Understanding of validation practices and processes in a GXP … more
- Kelly Services (Tampa, FL)
- …a robust quality management system + Assist in the development and execution of validation protocols for computer systems and software applications + Conduct ... **Junior CSV Validation | Tampa, FL** **Contract-To-Hire (Full Benefits)** **_*This...ensure compliance with regulatory requirements, including FDA, ISO, and GxP + Provide training and support to end-users on… more
- Boehringer Ingelheim (St. Joseph, MO)
- …validation project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's ... (VMP) and Corporate Policies and Procedures. + Maintains site validation database and document systems , supports feasibility...detail. + * This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for… more
- Merck (Rahway, NJ)
- …them between the development and business-facing teams, and documenting them for GxP systems . + Drives continuous product discovery to understand user ... of critical QMS processes, including Content Management and Digital Validation . The Digital Validation Product Analyst will...designing, and testing activities and engaging support teams for GxP products. You will also work closely with the… more
- System One (Summit, NJ)
- …Knowledge of cGMP, GXP , GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. + ... Job Title: Validation Engineer Location: Summit, NJ Type: Contract Responsibilities...+ Provides technical support and guidance on equipment and computer systems qualification and validations issues. +… more
- WuXi AppTec (Philadelphia, PA)
- …review, and approval of equipment/software validations (including Computerized Laboratory Systems ), System Life Cycle Documentation ( Validation Plans, Design ... approve Periodic Reviews. * Stay current with changes to GXP , including FDA and EU and other regulatory bodies...accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, Outlook, and… more
- Lilly (Indianapolis, IN)
- …compliance to corporate Computer System Validation (CSV) expectations for global computer systems including GMP Computer systems , critical ... use cases, and related testing and validation + Experience in computer system quality assurance, preferably with AI/ML systems . **Additional Preferences:** +… more
- The Estee Lauder Companies (Blaine, MN)
- …and operating systems to eliminate risk of downtime on PC's when patching systems that have locally installed GxP Applications as well as web accessed ... global team to deploy the backup process for all GxP in-scope systems and non- GxP ...principle for regulatory compliance (ie, user access, audit trail, computer system validation ) would be a plus.… more
- Bausch Health (Bridgewater, NJ)
- …and approving Change Requests, interfacing with internal and external auditors and ensuring all GxP systems are maintained in a validated state. This role will ... is responsible for Software Quality Engineering processes ensuring the development of GxP computerized systems to meet business process requirements and to… more