- Kedrion Biopharma (Melville, NY)
- …aseptic process introduction into clinical and commercial facilities, the Associate Validation Specialist must integrate and successfully utilize knowledge ... in hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Associate Validation Specialist at Kedrion provides technical input to… more
- Lilly (Indianapolis, IN)
- …external audits as required. **Basic Requirements:** + Bachelor's degree in Life Sciences field, Engineering, Pharmacy, Pharmaceutical Science , or related field ... Analytical Quality & Integrated Services team within the Global Quality Analytical Sciences & Quality Control Operations (AQCO) organization is seeking a Computer… more
- Bristol Myers Squibb (Summit, NJ)
- …place than here at BMS with our Cell Therapy team. T he Associate Director, Computer Systems Validation (CSV), Equipment Commissioning & Qualification (ECQ) ... supports the activities and personnel associated with design, development, delivery, validation , maintenance and support of GMP computerized systems at multi-use… more
- Danaher Corporation (Fargo, ND)
- …development and delivery of solutions that safeguard and improve human health. The Process Validation Engineer II is part of the Technical Operations Department ... discoveries worldwide. You will be a part of the Process Validation team and report to the...Biology, or Microbiology) and 2+ years of experience in process development and/or technology transfer OR Associate … more
- Santander US (Boston, MA)
- Risk Model Validation Associate - GenAI & Machine Learning Country: United States of America **Your Journey Starts Here:** Santander is a global leader and ... **We Want to Talk to You!** **The Difference You Make:** The Risk Model Validation Associate conducts robust validations of a wide variety of risk models… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …Engineering, Chemistry, Biological Sciences , or a related field; or an Associate 's degree with relevant direct validation experience in the biopharmaceutical ... We embody our core values of being Inspired by Science , Embracing Diversity, Fostering Talent, and Connecting Lives. Our...for patients worldwide. Position Summary As a Senior Specialist, Validation Services, you will play a key role in… more
- Novo Nordisk (Petersburg, VA)
- …a relevant field of study from an accredited university required + May consider associate 's degree in Life Sciences , Chemistry, Engineering or a relevant field ... help us make what matters. The Position Plan, manage & performing laboratory validation activities on computer software systems. This role will also be responsible… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …not limited to qualification of equipment, utilities, automation, shipping, and validation of cleaning, sterilization, decontamination, and aseptic process ... We are currently looking to fill a Director, QA Validation (Drug Product) position. This position leads department responsible for Drug Product Qualification/… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director, Clinical Systems** Reporting to the Director, Clinical Systems ... configuration, and ongoing support of Veeva's CTMS and eTMF within life sciences companies, ensuring efficient clinical operations by optimizing system usage and… more
- Fujifilm (Thousand Oaks, CA)
- …company, our community, and the world at large. **Job Description** Reports to: Associate Director, QA Validation Location: Thousand Oaks, California Travel: Up ... **Position Overview** The QA Validation Specialist will serve as technical subject matter...applicable standards and regulations. Experience Requirements: + Master of Science (M.Sc.) with 2+ years of applicable industry experience;… more
- Unither Pharmaceuticals (Rochester, NY)
- …are completed. Validation Protocols and Documentation (200%) Writes validation protocols ( process validations for, manufacturing and packaging processes. ... Computer Systems Validation Specialist Who we are? We are a...profile EDUCATION & EXPERIENCE: + Bachelor's degree in a science or engineering discipline preferred. An associate … more
- Synchrony (Costa Mesa, CA)
- …Provide support during regulatory examinations and internal audits of the model validation process by preparing necessary documentation, addressing inquiries and ... Job Description: **Role Summary/Purpose:** The AVP, Model Validation is responsible for model validation ...Master's degree (or foreign equivalent) in Statistics, Mathematics, Data Science or related quantitative field and 4+ years' experience… more
- Kedrion Biopharma (Melville, NY)
- …computer system validation projects related to authoring and executing validation documentation for QMS software, process equipment, automated equipment, and ... be a key contributor to Kedrion's drug product and process development, commercialization, and life cycle management of the...+ Ownership of all procedures related to computer systems validation + Train and mentor junior associate 's… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …a Gilead Sciences Company has an opportunity for an experienced Associate Director of Downstream Manufacturing Operations at our Oceanside biologics facility in ... for success and evaluate performance against metrics + Partner with Vector Process Development, Quality, Validation , Engineering, Maintenance, BSO, MSAT, and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …manages and completes all phases of assigned equipment, facilities, utilities and process qualification and validation activities. * Facilitates cross functional ... 110 countries and regions. **Overview:** The Engineer I - Validation / Engineer II - Validation /...**Specialist I** - Requires a BS/BA degree in STEM ( Science , Technology, Engineering, and Mathematics). An equivalent combination of… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …Join Gilead and help create possible, together. **Job Description** ** Associate Scientist, Pivotal Biologics Analytical Operations** **_At a future date, ... in preparation for commercialization. * Contributes to late-stage method validation activities internally and at external laboratories. * Independently plans… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …Join Gilead and help create possible, together. **Job Description** **Sr Associate Scientist, Pivotal Biologics Analytical Operations** **_At a future date, this ... Collaborate with IT to integrate analytical data into broader data science initiatives, supporting advanced data analysis and decision-making processes. . Coordinate… more
- Gilead Sciences, Inc. (Foster City, CA)
- …experienced SAP Batch Release Hub (BRH) Architect with a strong background in Life Sciences to lead the design and implementation of SAP Batch Release Hub solutions. ... regulatory compliance (such as GxP and FDA), and life sciences Quality Management and Batch Release processes. As an...other related systems (QMS, LIMS etc.,) and driving business process excellence in a regulated environment. This role involves… more
- Fujifilm (College Station, TX)
- …Excel, Word, and PowerPoint. **_Other_** **_Abilities:_** + Process Validation (PCPV)skillsandexperience withstrategydevelopmentand authoringof deliverables(eg ... ateam basedorganizationtoactivelyaddresscomplexcGMP manufacturing issues. The individualis responsible foranalyzing process technologiesinsupportofnew projectproposalsandtakes responsibility forthetechnical transferinto the manufacturing… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …aspirations. Join Gilead and help create possible, together. **Job Description** Gilead Sciences , Inc. is a biopharmaceutical company that has pursued and achieved ... Management & Segmentation** with a strong background in Life Sciences to lead the design and implementation of SAP...SAP Modules (PP, QM & EWM) and driving business process excellence in a regulated environment. This role involves… more
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