- PCI Pharma Services (Bedford, NH)
- …and database management skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems /software/equipment supporting GMP ... Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems from supporting GxP manufacturing and QC operations and… more
- Carrier (Beverly, MA)
- …day. Join us and we can make a difference together. **About this role** As a Computer Systems Validation Lead, you will lead and manage the Validation ... Program for Sensitech systems and products. The Validation Lead will work with the Sales, Product, Engineering, and Professional Services teams in the… more
- Kelly Services (Wilmington, DE)
- **Kelly Services is actively recruiting for a Computer Systems Validation Specialist for a Long Term Contract opportunity in Newark, DE.** Qualifications: ... The official position title is Computer System Validation (CSV) specialist to support...(CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems .… more
- Amgen (West Greenwich, RI)
- …work alongside other innovative, driven professionals in this meaningful role. **Specialist Computer Systems Validation Engineer** **Live** **What you will ... Serve as a lead with business and DTI partners for process and computer systems analysis, requirements elicitation, articulating system solutions and approaches… more
- University of Washington (Seattle, WA)
- …Department of Laboratory Medicine and Pathology has an outstanding opportunity for a ** Computer Systems GxP Validation Specialist** **WORK SCHEDULE** + 40 ... development, manufacture, and distribution. + Maintain an inventory of GxP computer systems , assess validation status, and prioritize actions based on… more
- Catalent Pharma Solutions (Chelsea, MA)
- …kind for DPI in North America. Catalent Pharma Solutions is hiring a Computer System Validation (CSV)/ Qualification Engineer is responsible for managing, ... developing, and implementing the Computer System Validation program and equipment qualification for the site to ensure compliance with local and global… more
- Takeda Pharmaceuticals (Boston, MA)
- …in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems , validation , and laboratory instruments. + ... at CTMF as the Subject Matter Expert (SME) in Computer System Validation requirements. Champion QA support...5 years in GMP developing equipment qualification, and computerized systems validation projects in a Quality Assurance… more
- Bristol Myers Squibb (Bothell, WA)
- …+ Expert knowledge of cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and data ... in respect to cGMP, GDP, GXP, GAMP5 regulations, including 21CFR Part 11, computer system validation requirements, EU GMP Annex 15 principles and data… more
- Eurofins (Columbia, MO)
- …role in the biotechnology/pharmaceutical industry with at least 2 years' experience with computer systems validation . + Minimum of five years' experience ... but are not limited to the following activities: Provide Quality oversight of Computer System Validation , Computer Software Assurance activities related to… more
- Kelly Services (West Hills, CA)
- …final reports, and route for approval as required. + Scheduling equipment and computer systems validation execution and documentation activities in ... apply. Kelly(R) Science & Clinical is seeking a Senior Validation Engineer for a temporary project at a leading...+ Knowledgeable in various areas of equipment and computerized systems with strong understanding of data integrity, life cycle… more
- PCI Pharma Services (Rockford, IL)
- …calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . + Computer Validation Focus: Ability to ... shape the future of PCI. **Summary of Objective:** The ** Validation Analyst I** is responsible for overall validation... computer tasks and have some experience with computer systems considered to have an impact… more
- Lilly (Lebanon, IN)
- … in the pharmaceutical industry **Additional Preferences:** + Direct experience with Computer Systems Validation (GAMP5) and data integrity basic ... applying and right-sizing validation requirements; maintaining corporate and site computer systems standards and practices; participating in internal and… more
- Curia (Albuquerque, NM)
- …+ Minimum of seven (7) years' experience working in a cGMP regulated industry specific to computer systems validation + Validation experience in a cGMP ... team. This position will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance… more
- Contract Pharmacal Corp (Hauppauge, NY)
- …) is responsible for providing system administration oversight for 21 CFR Part 11 Computer Validation Systems (CVS). This includes reporting and management ... Specialist; QA Compliance ( Computer Systems ) Hauppauge, NY (http://maps.google.com/maps?q=135+Adams+Avenue+Hauppauge+NY+USA+11788) Apply Description Position… more
- J&J Family of Companies (Columbus, OH)
- …Abiomed. + Develop and execute validation plans for new and existing GxP computer systems and digital solutions. + Support Validation Master Plan (VMP) ... Staff Computer System Validation (CSV) Engineer -...CSV Engineer will be responsible for ensuring that all computer systems and software applications used within… more
- Lilly (Indianapolis, IN)
- …operations. . Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and ... vendors, and other relevant functional areas. **Basic Requirements:** . BS degree in Computer Science, Information Systems or related discipline . 3+ years of… more
- BeiGene (Hopewell, NJ)
- …Strong + Experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). + Previous experience in a ... **_General_** **_Description:_** This position will provide leadership and support for IT Systems that enable the BeiGene Hopewell US Site Quality functions. They… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … computer system validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation documentation such as ... rare diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi... Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global… more
- Colgate-Palmolive (Hodges, SC)
- …(C&S) processes, water & critical utility systems , computer control systems , etc. Ensures site Validation Program appropriately connects to other plant ... activities, eg drafting/executing/completing equipment or instrument qualification, formula validations, computer system validation , etc.** + **Possess excellent… 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
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