- Catalent Pharma Solutions (Harmans, MD)
- ** Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing ... 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
- Astrix Technology (St. Joseph, MO)
- …80.00 | Pay Rate High: 85.00 + Added - 09/01/2025 Apply for Job We are seeking a Senior Computer System Validation (CSV) Engineer to play a critical role ... ** Computer System Validation Engineer**...Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports. + Validate GMP lab systems… 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 ... will work with lab & process automation, large corporate systems , small biotech systems , across all functions...corporate policies and procedures related to all aspects of computer system validation and applicable… 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
- Bayer (Berkeley, CA)
- …utilities, facilities, SIP, temperature mapping validation experience is desired; + Computer systems validation experience is desired; + Prior experience ... to make a real difference, there's only one choice.** ** Sr . Quality Assurance Validation Specialist - Berkeley,...to support assessment of critical issues and impact of validation on different elements of quality system … more
- Sanofi Group (Framingham, MA)
- …supporting the CSV program and computer systems + **Strong Computer System Validation knowledge** **SPECIAL WORKING CONDITIONS:** + Occasional ... and bring hope to patients and their families. The Computer Systems Validation (CSV) team...be responsible for providing technical guidance related to Sanofi computer system validation directives aligned… more
- Fujifilm (College Station, TX)
- …Life Sciences, Engineering, or similar discipline with 7+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or ... **Overview** The Senior Validation Engineer, with minimal supervision,...System Impact Assessment (SIAs) and drafting and executing validation protocols for Facilities, Utilities, Systems and… more
- Integra LifeSciences (Plainsboro, NJ)
- …: * Equipment Qualification * Process Validation * Cleaning validation * Computer System Validation * Test Method Validation * Temperature ... to advance patient outcomes and set new standards of care. Qualified candidates for this ** Senior Validation Engineer** must be experienced in one or more of the… more
- Catalent Pharma Solutions (Madison, WI)
- … validation program, including commissioning and qualification, cleaning validation , and computer system validation as well as the activities required ... ** Senior Engineer I, Validation ** Catalent, Inc....+ Provides guidance and oversight for commissioning, qualification, and validation of systems and processes + Drafts,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as Facilities, Utilities and Equipment, Cleaning (CIP/COP), Sterilization (Autoclaves & SIPs), Computer System Validation (PCS/PAS, BMS, CMS, DeltaV, OSI ... Demonstrate basic experience in validation disciplines (equipment, facilities, critical systems , computer , cleaning, process to also include HVAC and… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Junior ( Senior Associate) Computer Systems ...the Biologics IT team in the enhancement of existing computer system validation programs for ... the validation of new and existing laboratory computer systems , including major capital projects and...reviews, executes and approves protocols and reports related to Computer System Validation (CSV); +… more
- IQVIA (Greensboro, NC)
- …the proper implementation of Software Development Lifecycle (SDLC) methods as they relate to Computer Systems Validation (CSV), IT Quality Systems , and ... **Job Profile Summary** This Sr QA Auditor will work with IQVIAs wholly...compliant with 21CFR Part 11. + Expert knowledge of Computer Systems Validation (CSV) in… more
- Fujifilm (Holly Springs, NC)
- …Engineer 2, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation (CSV). This role provides input and determine ... action items on all GxP Manufacturing and IT Computerized Systems as well as prepares validation documentation,...Science, or related fields, with 6 years of direct Computer System Validation experience in… more
- Curia (Albuquerque, NM)
- …equipment and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), ... Senior Principal Validation Engineer in Albuquerque,...validation protocols for processes, equipment, utilities, and test systems . The role also supports new product introductions, equipment… more
- Lilly (Indianapolis, IN)
- …(eg, observations, deviations, analytical investigations, change controls, equipment qualifications, computer systems validation , method validation ... + Review change controls for global computer systems /lab applications + Review and approve validation ...requirements + Extensive knowledge of quality documentation, data integrity, computer system validation , and control… more
- Fujifilm (College Station, TX)
- …of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with ... **Overview** The Senior Computerized Systems Validation ...in computerized systems validation . + Computer System Validation experience with… more
- Bristol Myers Squibb (Princeton, NJ)
- …with peers across BMS on procedures relating to quality, data integrity and computer system validation . At BMS, digital innovation and Information ... Read more: careers.bms.com/working-with-us . **Summary:** Execute Computer System Assurance (CSA) and qualification efforts for systems...of 2-4 years of experience in IT Compliance and computer systems validation (CSV) in… more
- Lilly (Lebanon, IN)
- …years of relevant experience + 1+ years of experience in Automation/QC Labs/IT, Quality, computer system validation or data integrity in the pharmaceutical ... application of data integrity principles in Mfg/Fume/Lab processes; and computer system development/ validation methodologies...industry **Additional Preferences:** + Direct experience with Computer Systems Validation (GAMP5) and… more
- UL, LLC (Princeton, NJ)
- …working with potential and existing clients and providing deep expertise in computer system validation , strategic road-mapping, tactical planning, business ... of the ComplianceWire LMS. + Support clients with Computerized Systems Validation (CSV) project activities, including planning...in the life sciences industry. + Extensive knowledge of Computer System Validation (CSV)/ Computer… more