- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, ... 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
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, Change Control, Client interface, Lab… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Essential Functions QA approver for internal computer system validation efforts. Act as liaison to the business for ... guidance and consultancy on system validation . Support computer system audits for review of SDLC and data integrity controls. Review CAPA and… more
- Catalent (St. Petersburg, FL)
- …Shipper Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems ; b) process improvement projects and Product Development ... QA Product Manager Position SummaryThe QA Product Manager ...has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control.The QA… more
- Merck & Co. (Durham, NC)
- …both written and oralEffective maintenance, troubleshooting, and problem-solving skillsProficiency in computer systems and applications including but not limited ... skids, chromatography columns).Support Equipment (eg washers, autoclaves, tube welders/sealers).Automated Systems (eg Distributed Control System (DCS), Programmable… more
- Merck & Co. (Durham, NC)
- …refrigeration systems ).Good oral and written communication skills Proficiency in computer systems and applications including but not limited to:- Microsoft ... generation/distribution, reverse osmosis skids, compressed gas systems ) Automated Systems (eg Distributed Control System (DCS), Programmable Logic… more
- Cook Medical (Pittsburgh, PA)
- …motivated by helping others, and driven by integrity, we invite you to apply. The Computer System Validation Manager at Cook MyoSite, Inc. manages ... and computer system hardware. The Computer System Validation Manager...for validation approaches to computer systems and IT infrastructure. The information technology manager… more
- Takeda Pharmaceuticals (Boston, MA)
- … systems . + Understand development of CSV and equipment specifications and execute Computer System Validation , System Development Life Cycle (SDLC), ... therapies to patients worldwide. Join Takeda as a Senior Manager , Cell Therapy Systems and Validation...the site and contribute to process improvements regarding new system validation and continuing qualification efforts. **Minimum… 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
- HP Inc. (Boise, ID)
- …role is responsible for leading managers and individual contributors responsible for Enterprise System Validation . This team is located in Boise, Korea, and ... quality during development, engaging with multiple stakeholders for managing validation activities, and identifying process improvement and cost reduction… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …quality oversight and support for process, cleaning, shipping, computer system , equipment and instrument qualification and validation activities + ... of validation standards as they apply to facilities, utilities, equipment, computer systems , cleaning and processes. Additionally, person in this role is… more
- Bristol Myers Squibb (Bothell, WA)
- …relevant GMP operations experience. + A minimum of 5 years of equipment qualification or computer systems validation experience. + A minimum of 5 years of ... validation in a biopharmaceutical environment. + Experience in use of computer systems related to validation , calibration, maintenance, change control,… more
- ThermoFisher Scientific (Greenville, NC)
- …and documentation of validation for manufacturing equipment, utility systems , facilities, and manufacturing processes and computer /information./automation ... **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Manager , Validation ** **How you will make an impact** Lead a… 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
- Bristol Myers Squibb (Devens, MA)
- …required. + A minimum of 7+ years relevant experience with process equipment, computer systems , manufacturing process control systems (automation) and ... in their personal lives. Read more: careers.bms.com/working-with-us . The Manager , Sr. Validation Engineer I supports the...for communicating the status of assigned projects all GMP systems maintained by Validation Engineering to all… more
- Bristol Myers Squibb (Princeton, NJ)
- …Location: 100 Nassau Park Blvd, Princeton, NJ, 08540 **Duties:** Use experience with: computer system validation , electronic records and electronic signature ... big data platforms, data warehousing, integration technologies to oversee and executes Computer System Validation activities for Information Technology (IT)… 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 /...configuration, and fundamentals of heating, air conditioning, and refrigeration systems . + Computer Validation Focus:… more
- ManpowerGroup (Rocky Mount, NC)
- …**PHYSICAL/MENTAL REQUIREMENTS:** Mathematical and scientific reasoning ability. Occasionally lift a computer system and/or instrument up to 50 pounds. Use ... role which, under the guidance of a more senior Validation Engineer or Manager , is responsible for...and written, and attention to detail. Mastery of core computer software/ systems (Word, Excel, Sharepoint, Teams, etc.).Excellent… more
- Microsoft Corporation (Redmond, WA)
- …(such as System on Chip(SoC) FWs, Basic Input Output Systems (BIOS), Baseboard Management Controllers(BMC), Rack Manager etc.). + Collaborate with ... 5+ years of professional experience in validation , design/development, integration, or system level debugging in firmware/embedded systems . + 5+ years of… more
- Qualcomm (San Diego, CA)
- …+ The overall technical disciplines, languages and methodologies included in Soc validation team are: ** System debug** (emulation, SoC architecture, HW platform ... low power, virtual memory, MMU, debug). + **The SoC system infrastructure validation team is a part...clock, PMIC (power management integrated circuit), RPM (resource power manager ) et al HW blocks across mobile / AI… more