- Kedrion Biopharma (Melville, NY)
- …agency requirements, internal company standards and current industry practices. The focus of the Computer Validation Specialist role is to identify or create ... in hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Computer System Validation Specialist at Kedrion serves as SME (Subject… 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 ... and Design Specifications. If completed by an external company, the computer systems validation (CSV) specialist will be responsible for obtaining these… more
- Cognizant (Muskegon, MI)
- …work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible ... Sr/Lead CSV Specialist Cognizant Technology Solutions in LSMG is seeking...to assist Client in designing the validation strategy for the overall project and to coordinate… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory requirements ... 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might include:**... validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing,… more
- VTI Life Sciences (San Diego, CA)
- …of the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that ... policies. The role includes the development and execution of validation protocols, risk assessments, and documentation to support the...+ 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation . + Must… 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 … more
- Fujifilm (College Station, TX)
- …of Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, engineering design ... **Position Overview** The QA Specialist III, QA Validation , will be...in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/… more
- Catalent Pharma Solutions (Harmans, MD)
- **Lead Specialist , QA Validation & Engineering** Catalent Pharma Solutions is looking to hire a **Lead Specialist , QA Validation & Engineering** to ... will house 8 CGMP manufacturing suites and cold storage warehousing. The **Lead Specialist , QA - Validation & Quality Engineering** is responsible for providing… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- **Senior Cleaning Validation Specialist ** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... your most difficult development and manufacturing challenges The **Senior Cleaning Validation Specialist ** position involves creating cleaning cycle development… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The primary responsibility for the Validation Specialist is the planning and overall approval of ... of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (eg Computer , Equipment, Cleaning, Process, etc.) preferred… more
- Envista Holdings Corporation (Madison, WI)
- **Job Description:** **Position Summary:** The ** Validation Specialist ** is primarily responsible for developing and executing validation protocols for new ... process issues. **Essential Duties and Responsibilities:** + Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems, including… more
- United Therapeutics (Silver Spring, MD)
- …an engineering degree will still be considered; however, the job title will be as a Validation Specialist ) + 8+ years of relevant validation experience in a ... Datalogger Software (preferably Amphenol / Ellab) + Ability to perform validation activities for equipment, process and/or computer -related validation … more
- Lotte Biologics USA LLC (Syracuse, NY)
- …to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist , Validation Services, you will play a key role in supporting ... and leading validation activities, ensuring protocols and reports meet LOTTE BIOLOGICS...Repetitive use of arms/hands/wrists, especially when working with a computer . Work Environment This position is based indoors in… more
- Astellas Pharma (Sanford, NC)
- ** Specialist , QA Validation ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to ... For more information, please visit our website: www.astellasgenetherapies.com. **The Role** The Specialist , QA Validation will be primarily responsible for the… more
- Kelly Services (West Point, PA)
- **Job Title:** **Instrument Validation Specialist ** **Responsibilities:** + Manage equipment assets at multiple locations. + Gain a working knowledge of ... communicate with the vendor/service engineer to identify resolutions. + Participate in computer system validation activities associated with new or upgraded… more
- BioBridge Global (San Antonio, TX)
- …to ensure successful collaboration and equipment relocation and verification and/or validation . Professionalism and diplomacy in dealing with other Departments is ... Tasks Independently design, execute, and interpret results for laboratory experiments/ validation studies to evaluate and/or validate laboratory processes, test… more
- Novo Nordisk (Clayton, NC)
- …us make what matters. The Position Primary responsibility is to provide/lead validation services required for the successful delivery of highly automated warehouse ... Senior Project Manager, Site Capacity & Upfit. Essential Functions + Provide validation & technical support through the preparation, execution, data analysis, &… more
- Mentor Technical Group (Juncos, PR)
- …and South America. Job Summary: We are seeking a meticulous and experienced Validation Engineer specializing in Serialization to join our team. The ideal candidate ... meet industry standards and regulatory requirements. This role involves designing validation test methods, conducting process validation studies, preparing… more
- AbbVie (North Chicago, IL)
- …of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (eg Computer , Equipment, Cleaning, Process, etc.) preferred ... to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes… more
- The Greentree Group (Madison, WI)
- Independent Verification & Validation (IV&V) Technical Specialist + A re you a technology enthusiast who loves solving complex problems? + Do you have a keen eye ... ABOUT THE OPPORTUNITY As a potential Independent Verification & Validation (IV&V) Technical Specialist , you will have...in Engineering in a related technical field (eg Electrical, Computer ). + Minimum of three (5) years of hands-on… more
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