- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... We are seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… 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 at ... + Stay current with industry trends and regulatory updates related to computer system validation . **Qualifications:** + Bachelor's degree in Computer… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... is hiring a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Boehringer Ingelheim (Ridgefield, CT)
- …depending on process and technical risks Proactive and consultative engagement of the Computer System Validation role within agile projects 2. Guide business ... by conducting self-developed, process adapted training. Give active feedback into the Computer System Validation (CSV, Management System Owner (MSO) Network on… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… 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 within the Bioanalytical Discovery and Development Sciences (BDDS). We work with internal bioanalytical groups to… more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims 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
- Lilly (Indianapolis, IN)
- …(API) and parenteral manufacturing for future injectable therapies (Drug Product). The Computer System Validation Engineer is an Engineering role that will ... Process Automation & Control Engineering team (GPACE). It will support Computer System Validation and Data Integrity processes and methods related to Lilly's… more
- Cognizant (Muskegon, MI)
- ** Computer System Validation Engineer (ONSITE)** **Cognizant's Digital Engineering** Our practice is seeking a highly qualified Computer System Validation ... Lead, Automation Lead, and Project Manager. + Perform initial Computer System Validation (CSV) at client sites for systems including DeltaV, Historian, MES,… 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
- Curia (Rensselaer, NY)
- …validation areas (Equipment qualification, packaging, cleaning, utilities, process or computer validation ). Expert in cGMP documentation practices. + ... process and cleaning validation protocols and master plans, supervises validation activities such process/ equipment/ cleaning/ computer system validation… more
- Novo Nordisk (Durham, NC)
- …one or more core validation areas (equipment, cleaning, process, or computer validation ) preferred + Experience in cGMP documentation practices & regulations ... Position Coordinate & drive implementation of science & risk-based validation . The incumbent will provide input to project team...required + Basic computer skills including experience in the use of Microsoft… 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 be ... for IQ/OQ/PQ, installation, operational, and performance qualifications. R eview laboratory validation procedures & completed validation protocols for accuracy,… more
- Actalent (St. Paul, MN)
- …Cleaning Validation program. + Develop, execute, and maintain a robust Computer System Validation program. General: + Develop, update, maintain SOPs and ... Qualification requirements + Working knowledge of Process Performance Qualification and Process Validation requirements. + Working knowledge of Computer System … more
- Regeneron Pharmaceuticals (Troy, NY)
- We are hiring a Principal QA Validation Specialist to support validation and qualification of computer systems within IOPS. The Principal QA Validation ... Specialist would also plan, coordinate and participate in compliant computer system validation (CSV) process for systems which require formal validation … more
- Danaher Corporation (Chaska, MN)
- …+ Knowledge of FDA regulations, ISO standards, and GxP guidelines. + Experience with Computer System Validation (CSV) and process validation It would be ... address the world's biggest health challenges. The Senior QA Validation Engineer for Beckman Coulter Diagnostics is responsible for...for assisting in the sustainment of a robust Master Validation Plan and support of the MVP strategies. This… more
- West Pharmaceutical Services (Williamsport, PA)
- …knowledge of validations in a Medical Device environment. + Good understanding of computer system validation . + Familiarity with SAP, Master Control or similar ... Validation Engineering Technician Requisition ID: 68973 Date: Apr...location. Thank you.** **Job Summary** This role will support validation projects with key focus around customer specification, … more
- United Therapeutics (Silver Spring, MD)
- … Datalogger Software (preferably Amphenol / Ellab) + Ability to perform validation activities for equipment, process and/or computer -related validation ... currently an option. **Who you are** Are you a validation professional looking to apply your expertise in a...a dynamic biotech and pharmaceutical environment? As a Lead Validation Engineer, Equipment, you'll be a subject matter expert… more
- System One (Bellevue, WA)
- …Design Basis Accident (DBA) Without Radionuclide Release * Nuclear safety analysis computer code assessment, verification and validation The Senior Safety ... the guidance in NRC's RG1.203. * Perform and coordinate safety computer code verification and validation test programs, including SETs and IETs * Support and… more
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