- Formation Bio (New York, NY)
- …Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation ( CSV ).The primary responsibilities ... enabled development organization, there is a substantial component of oversight for the computer systems validation . The implementation of the QA strategy… more
- Insmed Incorporated (NJ)
- …seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation ( CSV ) program. This role ... protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in...mitigation strategies CSV Program Oversight: Oversee the CSV team, validation strategy and continuous process… more
- Curia (Albany, NY)
- …contributions + Learning platform + And more! Responsibilities Computer Systems Validation + Manage multiple site and global CSV projects at any time + ... CSV Systems Engineer II/III in Albany,...field + Minimum 3 years' experience in quality and computer systems validation and/or information… 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 ... validation strategies for system implementation and changes following CSV SOPs and Work Instructions Coordinate all validation...Clinical/Manufacturing systems .Minimum of a Bachelor's Degree in Computer … more
- Insmed Incorporated (NJ)
- …hands on experience in a validation role with responsibility for computer systems specifically LIMS, Empower, BMRAM, Chromeleon, environmental monitoring ... Provide operational support like change controls, release management, and reviews of validated systems . Author CSV Documents ( Validation Plans and Summary… more
- 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 ... limited to the following: Provide strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and… more
- Syner-G BioPharma Group (Boston, MA)
- …of automated production systems , with a concentration on computerized equipment and systems validation .Report writing experience for IQ, OQ, PQ, and CSV ... (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems , equipment, and processes for (re)qualification/(re)verification.Support validation … more
- Cipla (Fall River, MA)
- …IT Manufacturing, Packaging and WH Systems support including IT administration, Systems Validation , PLC. SAP Skills in Production, WH, Packaging and Quality ... Cipla support functions and vendors / partners. This role will perform IT Systems Support including Systems Implementation, Validation , Administration etc.,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preferred.Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.Experience with Computer System Validation ... tasks.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.May support CSV activities as needed.May support… more
- Insmed Incorporated (NJ)
- …LMS applications, compliance business, and IT infrastructurePrevious experience managing computer systems in pharmaceutical environmentsKnowledge of System ... System Owner for the Learning Management System and compliance IT systems , which includes supporting GxP-regulated applications, while also functioning as strategic… more
- Caris Life Sciences (Tempe, AZ)
- …preferred. + Experience integrating data from LIMS, instruments, and environmental monitoring systems ; familiarity with GxP/ CSV practices. + Working knowledge of ... assay QC/QM data from LIMS, instruments, environmental sensors, and production systems ; ensure, auditability, and SLA-based reliability. + Define canonical data… more
- Unither Pharmaceuticals (Rochester, NY)
- …Specifications, Functional and Design Specifications. If completed by an external company, the computer systems validation ( CSV ) specialist will be ... Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Specialist would also plan, coordinate and participate in compliant computer system validation ( CSV ) process for systems which require formal ... are hiring a Principal QA Validation Specialist to support validation and qualification of computer systems within IOPS. The Principal QA Validation … more
- NTT DATA North America (Pittsburgh, PA)
- …workflows. Experienced in delivering projects in regulated environments, ensuring compliance with FDA Computer Systems Validation ( CSV ) and quality ... accountability and communication structures. Required Qualifications Bachelor's degree in Computer Science, Information Systems , Business, or related field.… more
- Cognizant (Boston, MA)
- … to guarantee seamless integration across platforms and systems . + Manage Computer System Validation ( CSV ) activities in alignment with global regulatory ... will make an impact by leading the testing and validation strategy for enterprise-level Document Management Systems ...and validation strategy for enterprise-level Document Management Systems (DMS) within the Life Sciences domain. You will… more
- PACIV (San Juan, PR)
- …Sets: + Strong DeltaV programming skills (especially batch processes). + Experience with computer systems validation ( CSV ) in regulated/GMP environments. ... including technical assessments and cost estimates. + Develop, review, and approve CSV documentation. + Ensure validation and compliance with policies, quality… more
- Lilly (Indianapolis, IN)
- …efforts. + Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems + Validation ( CSV ) of GMP assets including review and ... in a cGMP facility + Prior experience in C&Q, CSQ, and/or CSV + Proficient with computer systems including Microsoft Office, electronic document management … more
- Lilly (Indianapolis, IN)
- …Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation ( CSV ). + Proven ability to ... and release of data including data released from CM, stability, process validation , and reference standard characterization. + Utilizes technical skills to lead or… more
- Teva Pharmaceuticals (West Chester, PA)
- …+ Involved in implementation of new releases, upgrades and changes in accordance with Computer Systems Validation ( CSV ) standards. + Perform day-to-day ... to Software Development Life Cycle (SDLC) phases for laboratory computer systems . Ensures that system implementations are...+ Minimum 3 years of experience working in a validation analyst or similar role, preferably within the pharmaceutical… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation ( CSV ) & Compliance** **Position Summary:** Catalent, Inc. is a leading global ... Specialist is primarily responsible for leading, implementing and managing Computer System Validation ( CSV ) and...information systems + Author, review and approve CSV , DI and Validation related documents and… more
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