- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part… more
- Bristol Myers Squibb (Devens, MA)
- …more: careers.bms.com/working-with-us . **Summary:** We are seeking a highly skilled and motivated Computer System Validation (CSV) Engineer to join our team ... system change controls, deviations, and CAPAs related to computer systems . + Provide training and guidance...current with industry trends and regulatory updates related to computer system validation . **Qualifications:** +… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... involved in processing steps related to equipment, facility/utility and computer systems validation . This role...to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Approach depending on process and technical risks Proactive and consultative engagement of the Computer System Validation role within agile projects 2. Guide ... framework by conducting self-developed, process adapted training. Give active feedback into the Computer System Validation (CSV, Management System Owner… 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
- J&J Family of Companies (Spring House, PA)
- …**We are searching for the best talent for a Principal Scientist, CSV Lead ( Computer System Validation ) to be in Spring House, PA.** **Purpose:** ... This position is a computer system validation lead position...Familiarity with bioanalytical work and workflows, instrument software, and computer systems validation in the… more
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... and commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT… more
- Lilly (Indianapolis, IN)
- …ingredients (API) and parenteral manufacturing for future injectable therapies (Drug Product). The Computer System Validation Engineer is an Engineering role ... Automation & Control Engineering team (GPACE). It will support Computer System Validation and Data...agility and experience in one or more process automation systems with a strong focus on data, systems… more
- Cognizant (Muskegon, MI)
- ** Computer System Validation Engineer (ONSITE)**...+ Perform initial Computer System Validation (CSV) at client sites for systems including ... Digital Engineering** Our practice is seeking a highly qualified Computer System Validation Engineer with...DeltaV, Historian, MES, ABB, and other DCS and OT systems . + Review and approve risk assessments linked to… more
- Fujifilm (College Station, TX)
- … cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems , engineering design fundamentals, ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- Curia (Rensselaer, NY)
- …protocols and master plans, supervises validation activities such process/ equipment/ cleaning/ computer system validation etc. + Review and approve lab ... responsibility is to provide quality review and approval of validation activities associated with changes to existing systems...special projects as directed by management + Perform the computer system periodic reviews in coordination with… more
- Novo Nordisk (Durham, NC)
- …one or more core validation areas (equipment, cleaning, process, or computer validation ) preferred + Experience in cGMP documentation practices & regulations ... what matters. The Position Coordinate & drive implementation of science & risk-based validation . The incumbent will provide input to project team members through all… more
- Novo Nordisk (Petersburg, VA)
- …and help us make what matters. The Position Plan, manage & performing laboratory validation activities on computer software systems . This role will also ... protocols preferred + Experience in managing projects preferred + Experience with electronic validation systems (TIMS) and SAP PM and QM module a plus + Working… more
- Actalent (St. Paul, MN)
- …robust Cleaning Validation program. + Develop, execute, and maintain a robust Computer System Validation program. General: + Develop, update, maintain ... Demonstrated expertise in the development, execution, and maintenance of validation systems . + Strong knowledge of cGMP,...Process Validation requirements. + Working knowledge of Computer System Validation Requirements. +… more
- Regeneron Pharmaceuticals (Troy, NY)
- … Specialist would also plan, coordinate and participate in compliant computer system validation (CSV) process for systems which require formal ... a Principal QA Validation Specialist to support validation and qualification of computer systems...following: + Generates, executes and/or reviews master and completed computer system (s) qualification and validation … more
- United Therapeutics (Silver Spring, MD)
- … Datalogger Software (preferably Amphenol / Ellab) + Ability to perform validation activities for equipment, process and/or computer -related validation ... by either overseeing or else providing hands-on assistance during testing to either System Owners or Validation management + Ability to interact and communicate… more
- West Pharmaceutical Services (Williamsport, PA)
- …and knowledge of validations in a Medical Device environment. + Good understanding of computer system validation . + Familiarity with SAP, Master Control or ... Validation Engineering Technician Requisition ID: 68973 Date: Apr 18, 2025...similar systems and databases, a plus. + Must have a thorough understanding… more
- Danaher Corporation (Chaska, MN)
- …+ Knowledge of FDA regulations, ISO standards, and GxP guidelines. + Experience with Computer System Validation (CSV) and process validation It ... tools that address the world's biggest health challenges. The Senior QA Validation Engineer for Beckman Coulter Diagnostics is responsible for assisting in the… more
- System One (Bellevue, WA)
- …experience in nuclear safety software verification and validation activities and system transient analysis computer code benchmark. * Familiarity with EMDAP ... Design Basis Accident (DBA) Without Radionuclide Release * Nuclear safety analysis computer code assessment, verification and validation The Senior Safety… more
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