- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and requirements for validationDevelop and implement strategies for equipment IQ/OQ/PQ, process validation , computer system validation and ... and subject matter experts to prepare for FDA and other agency auditsEnsure site/ system validation program meets FDA, ISO and EU requirementsCollaborate with… more
- Aequor (Libertyville, IL)
- …of IT infrastructure (network, storage, server, cyber, cloud).Must have GMP and computer systems validation experience in pharmaceutical manufacturing.5&plus ... growth as well as integrating the site with enterprise systems . The role of the Sr . PM...infrastructure (network, storage, server, cyber, cloud).Must have GMP and computer systems validation experience in… more
- Merck & Co. (Durham, NC)
- …of raw materials, intermediates and finished products. The HVAC & R Senior Technician will provide maintenance supporting vaccine process equipment operations. Takes ... industrial HVAC & R environment is required, specifically industrial refrigeration systems which includes DX systems , chillers, cascade refrigeration, freezers… more
- Merck & Co. (Durham, NC)
- Job Description Job Posting Title - Senior Technician - - Position Description- This is a day shift position, 12.5 hour 6:00 AM - 6:30 PM rotation (2-2-3). - The ... Vaccine Manufacturing Facility Senior Production Technician is an excellent opportunity for highly trained individuals with expertise working in aseptic production… more
- Tris Pharma (Monmouth Junction, NJ)
- …FDA guidance documents in managing application/ system changes in accordance with computer system validation Experience implementing and leading IT change ... and overall priorities.She/he oversees day-to-day IT operations and business application system and provides leadership in management of IT Applications and… more
- Novo Nordisk Inc. (Durham, NC)
- …& hardware Perform system assessments & testing of operating systems , software, & hardware Perform automation/IT validation activities in accordance ... will provide support & management of hardware & software on quality control laboratory computer systems . This includes improving reliability of the QC lab … more
- Merck & Co. (North Wales, PA)
- …lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs ... on departmental strategic initiative teams Educational Qualifications :BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or… more
- Merck & Co. (South San Francisco, CA)
- …particularly in oncology. Experience with datasets from Akoya Phenocycler and/or Vectra systems , as well as comfort with image analysis commercial software and/or ... reusable analysis frameworks for imaging dataAssist in the development and validation of digital pathology infrastructure solutions for large file management… more
- 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
- 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
- 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 ... **Position 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
- Kelly Services (Eagan, MN)
- …Process Performance Qualification and Process Validation requirements. + Knowledge of Computer System Validation and Cleaning Validation ... Performance Qualifications and Process Validations. + Execute Cleaning Validations. + Implement Computer System Validations. + Develop, update, and maintain SOPs… more
- Kelly Services (Minneapolis, MN)
- …Utility, Equipment, and Process Performance Qualifications, as well as Cleaning and Computer System Validation programs. + **Collaboration & Support** ... Expertise** : Proven track record in developing and executing robust validation systems across multiple domains, including equipment, processes, cleaning, and… more
- Digital Prospectors (Woburn, MA)
- …quality and/or validation . + Hands-on experience with analytical instrument qualifications, computer system validation , and data integrity programs. + ... ** Senior Quality Assurance Validation Specialist** **Woburn,...systems . + Approve BMRAM work orders for lab systems . + Review and approve validation lifecycle… more
- IQVIA (Mooresville, 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
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