- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the ... 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
- 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
- Belcan (Indianapolis, IN)
- Computer System Validation (CSV) Program Lead Job Number: 352755 Category: -MFG & Supply Chain SBU Description: Job Title: CSV ( Computer System ... 1st #CSVLeadership #PharmaValidation #ComplianceExcellence Overview: We are seeking an experienced CSV ( Computer System Validation ) Program Lead to lead the… more
- Kelly Services (Deerfield, IL)
- …will own key tasks, demonstrate solid knowledge of validated systems and computer system validation , require moderate direction, give minimal guidance to ... **Top 3-5 Must Have Non-negotiable Skills Required** 1. Experience working in Computer System Validation (CSV) Documentation; Functional and Technical… more
- PCI Pharma Services (Rockford, IL)
- …calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . + Computer Validation Focus: Ability to ... validation plans for new customer / product / system project launch and maintains existing validated processes /... computer tasks and have some experience with computer systems considered to have an impact… more
- Fujifilm (College Station, TX)
- … cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems , engineering design fundamentals, ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- Boehringer Ingelheim (Athens, GA)
- …staff and other departments. + Leads and actively supports strategic direction of validation philosophies, improve overall validation system and process flow ... Master Plan (VMP) and Corporate Policies and Procedures. + Maintains site validation database and document systems , supports feasibility studies, equipment… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to...validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation… more
- Eastman (Kingsport, TN)
- …+ Working knowledge and expertise in computerized systems validation . + Computer System Validation experience with DCS, SAP, LIMS, etc. is preferred. ... across their lifecycle, ensuring adherence to regulatory standards, Computer Systems Validation (CSV), and...or similar discipline with 5+ Years of experience in Computer System Validation activities within… more
- Catalent Pharma Solutions (Madison, WI)
- … validation program, including commissioning and qualification, cleaning validation , and computer system validation as well as the activities required ... and corporate policies. + Provides guidance and oversight for commissioning, qualification, and validation of simple systems and processes. + Drafts and executes… more
- PACIV (Indianapolis, IN)
- …and compliance standards. If you're ready to step into a leadership role in computer systems validation and drive impactful change, the Principal ... CSV Program Lead to set up and oversee CSV ( Computer System Validation ) deliverables for...needs and trends to ensure ongoing compliance and validated system states for customer systems . Education and… more
- Insight Global (Clayton, NC)
- …of validation principles, including IQ/OQ/PQ protocols. -Experience with Process/Equipment/ Computer System Validation -Master's Degree Engineering or ... Areas where projects will be executed are in facility systems , aseptic formulation and filling, device assembly and packaging,...related field -Experience with computer system validation (CSV) and… more
- ThermoFisher Scientific (Greenville, NC)
- …* Strong understanding of validation principles, including equipment, process, and computer system validation . * Detailed knowledge of cGMP, FDA, ... protocols (IQ, OQ, PQ) for equipment, processes, and systems . * Ensure detailed and compliant validation ...and systems . * Ensure detailed and compliant validation documentation, including risk assessments, protocols, and final reports.… more
- Integra LifeSciences (Plainsboro, NJ)
- …: * Equipment Qualification * Process Validation * Cleaning validation * Computer System Validation * Test Method Validation * Temperature ... outcomes and set new standards of care. Qualified candidates for this **Senior Validation Engineer** must be experienced in one or more of the following areas… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …of above activities performed by a vendor, as needed. + Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. + ... take charge of your future at Takeda. Join us a Manager, Clinical Data Validation Engineer in our Cambridge, MA office. At Takeda, we are transforming the… more
- PACIV (Indianapolis, IN)
- …of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System ... Sciences, F&B and Utilities industries is looking for a full-time employed Senior Validation Engineer based at our USA office (Indianapolis) Job Description : The… more
- PACIV (Charlotte, NC)
- …Execute System Lifecycle deliverables from Commissioning and qualification (C&Q) and Computer System Validation (CSV) planning documents through ... PACIV, an international control systems integration and regulatory compliance engineering firm servicing...F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer, team member for our NC team. Job… more
- ThermoFisher Scientific (Santa Clara, CA)
- …cGMP, GDP, and regulatory requirements for automated systems . + Expertise in Computer Systems Validation . + Outstanding attention to detail and ability ... deliverables with outstanding attention to detail. + Write, review, and complete project validation protocols for both standard and customized systems . + Lead… more
- Insight Global (Indianapolis, IN)
- …have experience working in an environment with human safeties involved. It could be a Computer system validation process or a validation equipment ... Job Description Insight Global is looking for a Validation Engineer to support a large HVAC customer....will go through a series of CQV (Commission, Qualification, Validation ) within an FDA regulated environment for a pharmaceutical… more
- System One (Bellevue, WA)
- …in nuclear safety software verification and validation activities and system transient analysis computer codes development. + Familiarity with EMDAP ... Design Basis Accident (DBA) Without Radionuclide Release + Nuclear safety analysis computer code assessment, verification and validation The Safety Verification… more
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