- Insmed Incorporated (San Diego, CA)
- …hands-on experience in a validation role with responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical/Manufacturing systems ... Provide strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV… more
- Cipla (Fall River, MA)
- …documents. Preparation of qualification and validation documents of equipment and computer system . Preparation and qualification of e-batch record & e-Log ... Job Title : Mfg. Validation Engineer FLSA Classification : Professional, Exempt Work...with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive,… more
- Cipla (Hauppauge, NY)
- …General: 8:30AM - 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The incumbent to this ... (DPI, MDI, oral solid or Injectables preferred). Technical Knowledge and Computer Systems Skills Effective interpersonal relationship skills and the… more
- ValSource, Inc. (Rahway, NJ)
- …and cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... our regions in the US. The Commissioning, Qualification & Validation (CQV) Project Manager will interface with...guidelines, client requirements, and company SOPs. Field Verifications and system walkdowns to confirm systems meet design… more
- Insmed Incorporated (NJ)
- …years' experience in a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other ... reviews, and audit trail reviews.What You'll Do: Develop risk-based validation strategies for system implementation and changes...Clinical/Manufacturing systems .Minimum of a Bachelor's Degree in Computer … more
- Merck & Co. (Durham, NC)
- …above floor level. Walking, bending, crawling, and stooping is required.-Proficiency in computer systems and applications including but not limited to:- ... steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System … more
- The Computer Merchant, LTD. (Manassas, VA)
- …and Validation for corrective changes. Performing installations, rip-outs, testing, and validation of tactical systems . Assisting in configuring the lab in ... partners to ensure the flawless delivery and operation of these critical systems in laboratory and submarine environments. QUALIFICATIONS: Requires a Bachelor's or… more
- Cipla (Hauppauge, NY)
- …packaging record instructions. Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols. Specifically, ... perform posting of dispensed materials and samples into SAP system (ERP system ) and to perform other...of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and… more
- Cipla (Hauppauge, NY)
- …packaging record instructions. Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols. Specifically, ... perform posting of dispensed materials and samples into SAP system (ERP system ) and to perform other...of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and… more
- Cipla (Hauppauge, NY)
- …dispensing process. To perform posting of dispensed materials and samples into SAP system and to perform other transactions in SAP. Maintenance of standard weights ... manufacturing record instructions. Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols.… more
- Agile IT (San Diego, CA)
- …a€" Security & CMMC Compliance for Microsoft cloud and ona€'premises systems Microsoft GCC High Licensing (secure onboarding & lifecycle operations) Complementary ... Azure AD, or bulk policy changes) and to integrate security data between systems . Implement RMM (Remote Monitoring and Management) scripts to deploy patches or… more
- J&J Family of Companies (Raritan, NJ)
- …Johnson and Johnson is recruiting for an **Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager ** , located in either **Horsham, PA; ... J&J's Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework,...inspections. The Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager is… more
- Jabil (Hunt Valley, MD)
- …across cross-functional teams. This individual will be responsible for overseeing Computer System Validation (CSV) activities, ensuring compliance ... systems , and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation . +… more
- Auburn University (Auburn, AL)
- …Institute at AU **Division Name** Samuel Ginn Col of Engineering **Position Title** Manager , Validation Command, Edge Lab **Job Class Code** JA34 **Appointment ... Security at Auburn University seeks an accomplished technical leader to serve as Manager , Validation Command, Edge Lab. Reporting to the Senior Technical &… more
- Zimmer Biomet (Austin, TX)
- …empowered and recognised. **What You Can Expect** As a **Software Quality Manager ** you will be responsible for ensuring the quality, safety, and compliance ... of software developed for medical device robotic systems , including embedded, cloud-based, and mobile applications. In this role you will provide leadership and… more
- Micron Technology, Inc. (Longmont, CO)
- …products. **Position Summary:** We are seeking a highly qualified and strategic Senior Manager , SSD Product Validation Engineering to lead validation efforts ... multiple SSD programs. This role involves defining and implementing validation strategies, managing multi-functional teams, and ensuring alignment with product… more
- Google (Mountain View, CA)
- TPU Validation Manager _corporate_fare_ Google _place_ Mountain View, CA, USA **Advanced** Experience owning outcomes and decision making, solving ambiguous ... leading or managing ML accelerator verification teams. + Experience with pre-silicon validation on emulation platforms. + Experience with system -level and… more
- NVIDIA (Santa Clara, CA)
- …work, to amplify human creativity and intelligence. NVIDIA is looking for motivated System /Board Design Validation Engineers to use your creativity to work on ... the growth of the PC gaming market, redefined modern computer graphics, and revolutionized parallel computing. More recently, GPU...the highly inventive team. What you'll be doing: + System /board level debug and validation of NVIDIA… more
- PCI Pharma Services (Rockford, IL)
- …instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . ** Computer Validation Focus:** _Associate's Degree in ... protocols, validation statements, reports, summaries, and master validation plans for new customer/product/ system project launch... computer tasks and have some experience with computer systems considered to have an impact… more
- Endo International (St. Louis, MO)
- …and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other ... Interaction with colleagues at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation needs. + Need… more
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