- Eisai, Inc (NJ)
- …eTMF system related inspection readiness activities.Must have good understanding of computer systems validation and related processes. Knowledge and familiarity ... profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with RandD IT...including, but not limited to version releases, system updates, validation or user acceptance testing, and integrations with other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program… more
- Cytiva (Muskegon, MI)
- …Qualification (OQ), Performance Qualification (PQ), process validation (PV), cleaning validation (CV) and Computer Software Validation (CSV) protocols ... Engineer will be the subject matter expert for the validation strategy and maintain ownership of the Muskegon site... Master Plan.This position reports to the Quality Assurance Manager and is part of the Quality Assurance Department… more
- Eisai, Inc (Nutley, NJ)
- …Associate Director must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess and initiate ... of Eisai Clinical Computing Environment Support study migration, program validation , technical documentationManage J-Review set up, J-Review user access management,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …West Lebanon, NH bioproduction facility. Relationships Reports to: Automation Manager Number of subordinates with direct/indirect referral: None Essential Functions ... connected and functional Work with PM to conduct system testing and validation to ensure proper operation Programming and Configuration Assist with contractors to… more
- Merck & Co. (Durham, NC)
- …guided by policies, procedures and business plan; receives guidance from manager .Manage multiple priorities and advance several tasks in parallel.Must be flexible ... maintenance of clean utility systems.Assists with execution of automation, validation and additional testing, as required.Responsible for written documentation of… more
- Aldevron (Miami, FL)
- …and 4+ years of experience with automation, engineering, networking, or Computer System Validation required.Experience with either Allen Bradley, Siemens, ... of the Automation and Process Engineering team and report to the Manager , Process Engineering and Automation responsible for Automation and Manufacturing related… more
- Catalent Pharma Solutions (Somerset, NJ)
- **INTERNET POSTING** ** ** **Job Title:** Manager Computer System Validation and Data Integrity **City:** Somerset **State** : NJ **JOB DESCRIPTION** : ... business; Provide quality and regulatory oversight of the design, development, validation , implementation and ongoing maintenance and use of computerized GxP systems… more
- Bristol Myers Squibb (Indianapolis, IN)
- …to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing ... commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams.… more
- Catalent Pharma Solutions (Harmans, MD)
- **Job Title:** Manager , Computer Systems Validation **City:** Harmans **State** : MD **JOB DESCRIPTION** : + Serve as the QA-CSV liaison with the ... Engineering, Quality Control, IT and Validation organizations to support SaaS enterprise computer systems validation of Gene therapy like but not limited to… more
- Kedrion Biopharma (Melville, NY)
- …requirements, internal company standards and current industry practices. The focus of the Computer Validation Specialist role is to identify or create industry's ... clinicians in hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Computer System Validation Specialist at Kedrion serves as SME… more
- Bristol Myers Squibb (Devens, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position: Manager , Validation Engineer, Cell Therapy** **Location: Devens, MA** **Key ... Responsibilities** + Supports equipment qualification and validation activities by providing technical impact assessments and developing sound validation … more
- Lilly (Indianapolis, IN)
- …perform activities related to cleaning, sterilization, filter and temperature mapping validation in support of parenteral manufacturing. First point of escalation in ... deliverables, collaborate with cross functional team members to integrate validation activities in production schedules, ensure associated documentation adheres to… more
- Carnival Cruise Line (Miami, FL)
- The Manager , Data Validation is responsible for the design and delivery of the MAST data validation process for all brands within the Carnival Corporation. ... database build phase of the MAST Program + Oversee the end-to-end data validation process for core, reference and transactional data which includes. Receiving and… more
- Fujifilm (College Station, TX)
- …of Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, engineering design ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- Novo Nordisk (Bloomington, IN)
- … strategy and mentor engineers/senior engineers on execution. Relationships Reports to Manager , Validation . Essential Functions + Equipment Validation + ... relevant to equipment validation + Understand other validation technical disciplines, such as cleaning, computer ...other validation technical disciplines, such as cleaning, computer system validation , and process validation… more
- System One (Bellevue, WA)
- …Design Basis Accident (DBA) Without Radionuclide Release * Nuclear safety analysis computer code assessment, verification and validation The Senior Safety ... (EM) following the guidance in NRC's RG1.203. * Perform and coordinate safety computer code verification and validation test programs, including SETs and IETs… more
- Takeda Pharmaceuticals (Libertyville, IL)
- …support Takeda's mission to deliver quality products. You will report to the Quality Validation Manager . **About the role:** The Quality Validation Engineer ... focus on disciplines related to equipment, cleaning, process, control system and computer system validation . **How you will contribute:** + Experience applying… more
- Actalent (Wayne, NJ)
- …is responsible for facilitating and coordinating all activities of the Validation Department, ensuring continuous compliance with regulatory and company rules. ... Responsibilities + Develop and implement updates to the Master Validation Plan for the packaging facility alongside Engineering Staff, QA Director/QA Manager ,… more
- AbbVie (North Chicago, IL)
- …and overall approval of validation tasks. Under the direction of the Validation Section Manager , will participate in the implementation of the Validation ... of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (eg Computer , Equipment, Cleaning, Process, etc.) preferred… more
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