- Amgen (West Greenwich, RI)
- …work alongside other innovative, driven professionals in this meaningful role. **Specialist Computer Systems Validation Engineer** **Live** **What you will ... and DTI partners for process and computer systems analysis, requirements elicitation, articulating system solutions...Amgen corporate, GxP and SOX compliance requirements + Lead computer validation testing initiates with oversight of… more
- Catalent Pharma Solutions (Chelsea, MA)
- …its 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...and System Impact Assessment (SIA) for Computerized Systems . + Lead and conduct validation activities… 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
- 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,...expectations. **Key Responsibilities:** + Define and maintain a global Computer System Validation (CSV) methodology… more
- J&J Family of Companies (Columbus, OH)
- Staff Computer System Validation (CSV) Engineer... validation plans for new and existing GxP computer systems and digital solutions. + Support ... Johnson & Johnson Abiomed is recruiting for a **Staff Computer System Validation (CSV) Engineer.**...CSV Engineer will be responsible for ensuring that all computer systems and software applications used within… 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...(CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems .… more
- University of Washington (Seattle, WA)
- …of Quality System documentation and standard operating procedures (SOPs) for computer system validation . + Develop and standardize validation ... Department of Laboratory Medicine and Pathology has an outstanding opportunity for a ** Computer Systems GxP Validation Specialist** **WORK SCHEDULE** + 40… more
- PCI Pharma Services (Rockford, IL)
- …calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . + Computer Validation Focus: Ability to ... protocols, validation statements, reports, summaries, and master validation plans for new customer/product/ system project launches... computer tasks and have some experience with computer systems considered to have an impact… 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
- Eurofins (Columbia, MO)
- …in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation activities. This will include working closely ... and remain expert on the regulatory requirements pertaining to computer systems used in the manufacture and...System support documentation, including, but not limited to, computer system validation SOPs. +… more
- Eurofins (Columbia, MO)
- …in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation activities. This will include working closely ... and remain expert on the regulatory requirements pertaining to computer systems used in the manufacture and...System support documentation, including, but not limited to, computer system validation SOPs. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …issues with equipment/software used at CTMF as the Subject Matter Expert (SME) in Computer System Validation requirements. Champion QA support for continuous ... test script performance with IT. + Provide professional expertise, guidance, and in Computer System Validation and applicable regulatory requirements (21 CFR… more
- System One (Somerset, NJ)
- …and data interpretation. + Excellent problem-solving and communication skills. + Experience with computer system validation and knowledge of GAMP 5. + ... Title: Validation Engineer Hours: Mon- Fri 8:30-5:00pm Location: Somerset,...initiatives by analyzing process data and implementing corrective actions. System One, and its subsidiaries including Joule, ALTA IT… more
- Bristol Myers Squibb (Bothell, WA)
- …deliverable in respect to cGMP, GDP, GXP, GAMP5 regulations, including 21CFR Part 11, computer system validation requirements, EU GMP Annex 15 principles and ... cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU...URS, to the end of IQ/OQ/PQ and SR) and computer system validation (CSV) documents… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …efforts as needed. + Act as a subject matter expert on part 11 requirements and computer system validation (CSV). + Review and approve validation ... Engineer to represent St. Louis when globally deployed computer systems are implemented. Primary Responsibilities: +...etc.). + Competence in Medical Device Development Processes and/or Computer System Lifecycle validation compliance… more
- Eurofins (Columbia, MO)
- …include but are not limited to the following activities: Provide Quality oversight of Computer System Validation , Computer Software Assurance activities ... in the biotechnology/pharmaceutical industry with at least 2 years' experience with computer systems validation . + Minimum of five years' experience in… more
- Colgate-Palmolive (Hodges, SC)
- … activities, eg drafting/executing/completing equipment or instrument qualification, formula validations, computer system validation , etc.** + **Possess ... critical utility systems , computer control systems , etc. Ensures site Validation Program appropriately...applicable external regulatory requirements** + **Adapt new technologies and systems to the site Quality System ** **Required… more
- Sanofi Group (Ridgefield, NJ)
- …requalification activities for facilities, utilities, equipment, cleaning, and sterilization. For computer system validation , this position is responsible ... execute protocols and write reports for medium to complex equipment/ systems . The Principal Validation Engineer position is...science and 8+ years of relevant experience. + Strong computer system validation experience is… more
- Catalent Pharma Solutions (Bloomington, IN)
- …organizations + Understands validation technical disciplines, including equipment, cleaning, computer system validation , and process validation , ... is to manage projects relating to biopharmaceutical manufacturing equipment, critical computer systems , manufacturing processes and documentation to ensure the… more
- Integra LifeSciences (Plainsboro, NJ)
- …: * Equipment Qualification * Process Validation * Cleaning validation * Computer System Validation * Test Method Validation * Temperature ... and making headway to help improve outcomes. Qualified candidates for this **Senior Validation Engineer** must be experienced in one or more of the following areas… more