- Kedrion Biopharma (Melville, NY)
- …across automation and computer systems within a GMP production facility. Computer System Validation Specialist is responsible for managing, ... and clinicians in hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Computer System Validation Specialist at Kedrion… 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 ... completed by an external company, the computer systems validation (CSV) specialist will...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and… more
- Cognizant (Muskegon, MI)
- …engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The ... Sr/Lead CSV Specialist Cognizant Technology Solutions in LSMG is seeking...MES, ABB as well as other DCS and OT systems . **Requirements** : The Validation Lead responsibilities… 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 ... 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)
- …companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that ... Test Scripts. + 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation . + Must have experience working in an… more
- Regeneron Pharmaceuticals (Troy, NY)
- … Specialist would also plan, coordinate and participate in compliant computer system validation (CSV) process for systems which require formal ... 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
- Catalent Pharma Solutions (Harmans, MD)
- …This position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the ... **Lead Specialist , QA Validation & Engineering** Catalent...completion in a Quality role. + Support the Computerized System Validation Lifecycle to ensure compliance to… more
- Fujifilm (College Station, TX)
- … cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems , engineering design fundamentals, ... **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 (St. Petersburg, FL)
- …vessels, clean-in place systems , and parts washers. The **Senior Cleaning Validation Specialist ** also responsible for supporting the design, execution and ... **Senior Cleaning Validation Specialist ** **Position Summary** Catalent, Inc....department is responsible for ensuring that all facilities, processes, equipment/ systems and automated equipment used for GMP/GLP critical purposes… more
- Envista Holdings Corporation (Madison, WI)
- **Job Description:** **Position Summary:** The ** Validation Specialist ** is primarily responsible for developing and executing validation protocols for new ... protocols (IQ, OQ, PQ) for equipment, processes, and systems , including software. + Prepare comprehensive validation ...analysis and data interpretation. + Ability to quickly learn computer business systems and software required (ie… more
- BioBridge Global (San Antonio, TX)
- …agencies or clients. Train staff on validation protocols. Manage incoming validation tickets via the ticketing system to ensure validations are assigned ... Must be familiar with the equipment maintenance system , environmental monitoring system , and ticket management systems . Must be familiar with pulling reports… 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
- 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 ... test plans, and regulatory guidelines. + Proficiency in troubleshooting equipment and systems during validation activities. + Ability to manage multiple… 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
- Kelly Services (West Point, PA)
- …and/or communicate with the vendor/service engineer to identify resolutions. + Participate in computer system validation activities associated with new or ... **Job Title:** **Instrument Validation Specialist ** **Responsibilities:** + Manage equipment...participating in the validation of computerized laboratory systems or instruments (eg system Installation and… 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
- Novo Nordisk (Clayton, NC)
- …obtainment. Serves as a source of expertise in the group for validating new systems + Ensure compliance of validation protocols executed are aligned with local, ... us make what matters. The Position Primary responsibility is to provide/lead validation services required for the successful delivery of highly automated warehouse… more
- Mentor Technical Group (Juncos, PR)
- …and quality of serialized products. Key Responsibilities: + Develop and execute validation protocols for serialization equipment, processes, and systems . + ... records for all validation activities. + Analyze validation test data to determine whether systems ...Required Skills and Qualifications: + Bachelor's degree in Engineering, Computer Science, or a related field. + Proven experience… 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 ... to hear from you! ABOUT THE OPPORTUNITY As a potential Independent Verification & Validation (IV&V) Technical Specialist , you will have the opportunity to work… 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
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