- Daiichi Sankyo, Inc. (Bernards, NJ)
- … computer system validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation documentation such as ... around 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
- Eisai, Inc (Nutley, NJ)
- …Domain Knowledge College diploma or university degree in the field of computer science, information science, management information systems , or business ... such as Scrum. Experience in managing application / system changes in accordance with computer system validation , 21 CFR Part 11 and GxP policies and /or… more
- Novo Nordisk Inc. (Durham, NC)
- …& standard operating procedures with attention to high-level concepts a plus Computer literacy with associated systems preferred Ability to plan, coordinate ... purpose of this position is to contribute to the establishment of all utilities systems for the OFP site Durham. Responsibilities include, but are not limited to,… more
- Merck & Co. (Durham, NC)
- …of regulatory requirements in accordance with GMP manufacturing operations. Proficiency in computer systems and applications including but not limited to:- ... contractors and disciplines on scheduling repairs and maintenance of clean utility systems Assists with execution of automation, validation and additional… 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...Responsibilities: * Support Data Integrity Manager with validation of automated equipment and control systems .… more
- HP Inc. (Boise, ID)
- …responsible for leading managers and individual contributors responsible for Enterprise System Validation . This team is located in Boise, Korea, and India and ... quality during development, engaging with multiple stakeholders for managing validation activities, and identifying process improvement and cost reduction… 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
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …of validation standards as they apply to facilities, utilities, equipment, computer systems , cleaning and processes. Additionally, person in this role is ... Manager , QA Validation Department: QA ...of corporate objectives + Act as the quality / validation SME for Change Controls supporting GMP/GLP systems… 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
- Eurofins (Columbia, MO)
- …role in the biotechnology/pharmaceutical industry with at least 2 years' experience with computer systems validation . + Minimum of five years' experience ... excellence in a process driven regulatory compliant environment. The Validation Manager will be responsible to provide...limited to the following activities: Provide Quality oversight of Computer System Validation , Computer Software… more
- PCI Pharma Services (Philadelphia, PA)
- …to pioneer and shape the future of PCI. Job Title: ** Validation Manager - Sterilization, Sterility Assurance, and Utilities/Facilities** Department/Group: ... By: Dennis Gerlach Approved By: Nancy Dorr **Summary of Objective:** Validation Manager - Sterilization, Sterility Assurance, and Utilities/Facilities is… more
- Catalent Pharma Solutions (Bloomington, IN)
- …is to manage projects relating to biopharmaceutical manufacturing equipment, critical computer systems , manufacturing processes and documentation to ensure the ... and requirements of company policies and FDA regulations. **The Process Validation Manager 's responsibilities include managing multiple projects to provide… more
- Reynolds American (Winston Salem, NC)
- …in validations, quality or regulatory compliance. + Proficient with computer systems and common terminology + Experience handling validation activities is ... Validation Compliance Manager (Process Validation...and workload distribution; review deliverables for new and existing validation -relevant systems ; and perform audits of completed… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …If so, be empowered to take charge of your future at Takeda. Join us a Manager , Clinical Data Validation Engineer in our Cambridge, MA office. At Takeda, we are ... a vendor, as needed. + Adhere to SOPs for computer system validation and all GCP (Good...+ Knowledge of data flow between clinical data management systems , vendor devices and CDR. + Knowledge of clinical… more
- L'Oreal USA (Somerset, NJ)
- …regulations. Position contributions made to L'Oreal's safety, productivity and quality: The Validation Manager provides over-site of L'Oreal's Validation ... Home (https://careers.loreal.com/en\_US/content/Home) / Job Search (https://careers.loreal.com/en\_US/jobs/SearchJobs) / 188971 Manager , Safety Validation Somerset, NJ Apply… more
- PCI Pharma Services (Rockford, IL)
- …calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . + Computer Validation Focus: Ability to ... and meetings. Effectively communicates project goals and progress to Validation Supervisor / Manager . + Investigate ... computer tasks and have some experience with computer systems considered to have an impact… more
- Charles Schwab (Lone Tree, CO)
- …of how financial models are used in business contexts. This is a manager level individual contributor role in which the person will perform model validations ... soundness, data integrity, the control environment, and the software environment. This manager will have the opportunity to present work through formal model … more
- Sanofi Group (Ridgefield, NJ)
- … Validation . The Principal Validation Engineer will report to either the Validation Manager or directly to the Associate Director of Validation . The ... to write and execute protocols and write reports for medium to complex equipment/ systems . The Principal Validation Engineer position is part of Quality Assurance… more
- Qualcomm (San Diego, CA)
- …candidate will be responsible for Program Management for our System Validation & Emulation (SVE) Engineering team including the following responsibilities: + ... manner when metrics deviate significantly from Plan of Record. + Coordinates the validation work of multiple cross functional teams on assigned tasks with guidance… 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... Engineer. This position will report directly to the Manager , Quality Engineering. This is an onsite role in… more
