- Bausch + Lomb (Greenville, SC)
- …raw data used to support product and raw material release, validation /engineering studies, and equipment maintenance. + Ensure data and documentation meets ... the future. **Purpose of the Job** Review and approve data generated by the Greenville QA Chemistry Laboratory to... used to support product and raw material release, validation /engineering studies, and equipment maintenance. Assist with or lead… more
- Boehringer Ingelheim (St. Joseph, MO)
- …office application software (MS-Word, MS-Excel, MS-Outlook, PowerPoint). **Requirements for a Sr. Specialist Validation ** + A BS degree from an accredited ... Boehringer Ingelheim's high regard for our employees. The Principal Specialist , Validation manages all phases of higher...and within cross function teams. + Ability to analyze validation and production data to assess compliance… more
- Kedrion Biopharma (Melville, NY)
- …hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Associate Validation Specialist at Kedrion provides technical input to Kedrion's ... aseptic process introduction into clinical and commercial facilities, the Associate Validation Specialist must integrate and successfully utilize knowledge and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …regions. **Overview:** The Engineer I - Validation / Engineer II - Validation / Validation Specialist I position supports Fractionation, Purification, ... and validation studies to meet timelines. * Evaluate and analyze qualification/ validation data collected, while verifying acceptability of the data … 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
- Regeneron Pharmaceuticals (East Greenbush, NY)
- The QA Validation department is hiring! The Principal QA Validation Specialist validates and qualifies equipment, systems, and processes in accordance with ... Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data ...following years experience for each level: + Principal QA Validation Specialist : 8+ years + Staff QA… 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 ... If completed by an external company, the computer systems validation (CSV) specialist will be responsible for...and change in timelines. Understanding of FDA requirements for validation . The ability to analyze and interpret data… 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 ... and/or reviews master and completed computer system(s) qualification and validation protocols, summary reports and associated data ...years of experience per each level: + Sr. QA Validation Specialist : 5+ years + Principal QA… more
- Fujifilm (College Station, TX)
- **Position Overview** The QA Specialist III, QA Validation , will be responsible for the review and approval of commissioning/qualification/ validation ... and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA Validation , will handle all associated responsibilities in… more
- Curia (Rensselaer, NY)
- Senior Quality Assurance Validation Specialist in Rensselaer, NY Build your future at Curia, where our work has the power to save lives! Curia is a global ... platform + And more! Summary The Senior Quality Assurance Validation Specialist assists with the validation...process verification for the product performance and recommend process re- validation if needed + Analyze data and… 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 ... controlled temperature unit (CTU) operations. + Ability to perform data review and trend analysis to support validation... data review and trend analysis to support validation conclusions. + Familiarity with laboratory sample handling and… 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:**...carrying out, and reviewing master and completed qualification and validation protocols, summary reports and associated data … more
- Fujifilm (Thousand Oaks, CA)
- **Position Overview** The QA Validation Specialist will serve as technical subject matter expert for FDBC validation processes including but not limited to, ... (FUE), manufacturing and laboratory systems and computerized equipment (CSV), and validation software tools. The main responsibility for this role is to… more
- SMBC (White Plains, NY)
- …continuous improvement of the model quality and governance. The Sr Model Validation Specialist applies numerical, statistical and qualitative knowledge to ... of the Risk Management Department, the Model Risk & Validation department enhances the Model Risk Management framework for...and model development; and working with large and complex data sets. Ability to apply regulatory requirements outlined in… more
- Novo Nordisk (Durham, NC)
- …what matters. The Position Coordinate & drive implementation of science & risk-based validation . The incumbent will provide input to project team members through all ... & commissioning/qualification/verification. Subject matter expert for all NN corporate validation procedures. Perform revalidation on equipment/processes per approved timelines.… more
- Mentor Technical Group (Caguas, PR)
- …and results, maintaining comprehensive records for all validation activities. + Analyze validation test data to determine whether systems or processes meet ... and South America. Job Summary: We are seeking a meticulous and experienced Validation Engineer specializing in Serialization to join our team. The ideal candidate… more
- Kelly Services (Anasco, PR)
- …conformance with ISO 11607 for all SKU's packaged at Integra Anasco. * Data Gathering - Participate in the discovery and compilation of required documentation to ... documentation required, included but not limited to Change Control, Validation Protocols, Drawings, Routers, etc identified as required as...as required as part of the project needs. * Validation Executions - Participate in the validation … more
- Boehringer Ingelheim (Ridgefield, CT)
- **Compensation Data ** This position offers a base salary typically between $115,000 and $181,000. The position may be eligible for a role specific variable or ... IT application and template landscape. Takes active advises on setting up optimal validation strategies and ensures that all process and technical topics are fully… more
- VTI Life Sciences (San Diego, CA)
- …Life Sciences industries. We are looking to staff a highly motivated Validation Specialist / Engineer 1 responsible for delivering commissioning, qualification, ... and validation (CQV) services related to equipment, instruments, and systems...with Autoclave Qualification. + Experience with Kaye Validators and data loggers is a huge plus. + Previous experience… more
- Bristol Myers Squibb (Summit, NJ)
- …there's no better place than here at BMS with our Cell Therapy team. The Specialist or Senior Specialist , Data Integrity role is responsible for assisting ... the implementation and management of Bristol Myers Squibb's GMP Data Governance and Data Integrity program at... Integrity principles. + Must be familiar with system validation principles. + Must be familiar with the ALCOA+… more