- Merck & Co. (Durham, NC)
- …validation topics in regulatory inspections by presenting and defending validation documentation .Develop technical and manufacturing documents necessary for ... Specialist will primarily support vaccine drug manufacturing via Validation program execution and partnering with cross-functional teams (ie Maintenance,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a CQV Specialist (Contract Position) as part of the Technical Operations team based in Raritan, ... This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …system to implement changes associated with technical operations, engineering, and/or validation (generate, execute, and evaluate change requests) Revise and create ... documentation (SOP, batch records, reports) associated with technical operations, production, engineering, and validation Incorporate technical pre-planned… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Review and assess Corrective and Preventive Actions Reviews and approves validation documentation Reviews and assesses deviations; includes tracking, follow-up ... is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …/ trending. Possess signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action ... is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and… more
- Aequor (Thousand Oaks, CA)
- …following functions: a) Review and approve product MPsb) Approve process validation protocols and reports for Mfg. processes. c) Approve Environmental ... in site audits) Approve change-over completion) May perform work of QA Specialist EDUCATION/LICENSES Doctorate degree or Master's degree and 3 years of directly… more
- BioAgilytix (Boston, MA)
- …of a traditional lab analyst, peer reviewer, and new system implementation specialist . Tasks will encompass running assays, reviewing data, and devising and ... objectives. Playing a pivotal role in our project lifecycle, you'll conduct validation studies on a spectrum of biological samples, ranging from biologics and… more
- ATS Automation (Warminster, PA)
- …Requisition ID: 12489 Location: Warminster, PA, US, 18974 Date: Jun 18, 2024 Validation & Documentation Specialist ATS Scientific Products is seeking ... a full‐time Validation and Documentation Specialist in Warminster, PA to create and maintain various technical documents (eg, user manuals, equipment… more
- Regeneron Pharmaceuticals (Troy, NY)
- …company manufacturing standards policies and procedures. The day to day of a QA Validation Specialist could include, but are not limited to, the following: + ... areas. This area also validates and qualifies equipment, systems, documentation and processes in accordance with regulatory requirements and...of relevant experience for each level: + Associate QA Validation Specialist : 0 - 2 years… 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 ... programs reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist , Validation manages all phases of higher level, more complex… more
- Charles River Laboratories (Wayne, PA)
- Computer Systems Validation Specialist Req ID #: 223070...is up to date at all times. * Maintain validation documentation and files including the Master ... Plan (MVP) in defined locations per approved procedures. * Archive all validation documentation per approved procedures. * Write or assist in the writing of… more
- United Therapeutics (Silver Spring, MD)
- …diseases, and other orphan diseases. **How you'll contribute** The Senior Validation Specialist or Engineer, Equipment will perform activities independently ... techniques for problem-solving and decision-making + Perform gap analysis of validation documentation , systems, and practices. Communicate identified gaps… more
- Merck (Durham, NC)
- … validation topics in regulatory inspections by presenting and defending validation documentation . + Develop technical and manufacturing documents necessary ... Specialist will primarily support vaccine drug manufacturing via Validation program execution and partnering with cross-functional teams (ie Maintenance,… more
- Unither Pharmaceuticals (Rochester, NY)
- Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify ... assurance that all qualification/ validation activities, where appropriate, are completed. Validation Protocols & Documentation (40%) Writes validation … more
- Regeneron Pharmaceuticals (Troy, NY)
- …safely deliver medicine to the patients. The day to day of an Associate QA Validation Specialist could include, but are not limited to, the following: + ... investigations, corrective actions, change controls, SOPs, reports and other documentation **This role might be for you if you:**...of relevant experience for each level: + Assoc. QA Validation Specialist : 0 - 2 years… more
- Catalent Pharma Solutions (Princeton, NJ)
- **Position Title:** ** Validation Specialist ** M-F 1st shift **Summary:** _In this critical position,_ **_the Validation Specialist_** _is responsible for ... completion of project milestones and crucial technical tasks.*Review and approve validation documentation . + Assess the impact of changes to validated systems… more
- University of Washington (Seattle, WA)
- …Laboratory Medicine and Pathology has an outstanding opportunity for a **Computer Systems GxP Validation Specialist ** **WORK SCHEDULE** + 40 hours per week + Day ... + Experience requirement, minimum: 4 years of direct experience in validation in a clinical contract research organization, pharmaceutical, biotechnology, or… more
- 3M (MN)
- …control assessments, across applications, or within a single application. + Review validation documentation to ensure risk level is adequately reflected in ... Job Description: Job Title Senior Computer Systems Validation Compliance Specialist Collaborate with Innovative...the level of documentation detail + Ensure compliance requirements are documented, complete,… more
- Abbott (Abbott Park, IL)
- …medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Validation Specialist ** **About Abbott** Abbott is a global healthcare leader, ... attacks to blood disorders to infectious diseases and cancers. As the ** Validation Specialist ** , you'll conduct quality-related activities to deliver… more
- Amgen (West Greenwich, RI)
- …best work alongside other innovative, driven professionals in this meaningful role. ** Specialist Computer Systems Validation Engineer** **Live** **What you will ... out to Amgen corporate, GxP and SOX compliance requirements + Lead computer validation testing initiates with oversight of project resources and analysis of test… more
