- Merck & Co. (Durham, NC)
- … Specialist will primarily support vaccine drug manufacturing via Validation program execution and partnering with cross-functional teams (ie Maintenance, ... Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation . Position Description: GENERAL INFORMATION A Senior Engineer will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QC Specialist , Equipment Management as part of the Quality team based in Raritan, NJ. ... Role Overview The QC Specialist , Equipment Management is responsible for equipment lifecycle management...related to the QC laboratory. Experience developing content for Validation Life Cycle documents (eg, Master Validation … more
- Merck & Co. (Durham, NC)
- Job DescriptionWe are seeking a Growth and Improvement minded Associate Specialist Automation Technician who can help drive our Strategic Operating Priorities.- The ... manufacturing systems, in partnership with maintenance, technical operations, operations, validation , and quality personnel.Performs routine system monitoring and troubleshooting.Performs… more
- BioAgilytix (Durham, NC)
- …therapeutics to the patients who need them.The Senior Laboratory Automation Specialist will be primarily responsible for leading the programming and implementation ... project plans to implement automated solutions to support (GxP) validation and implementation, including protocol/throughput analysis; instrumentation specification; drafting… more
- Merck & Co. (Rahway, NJ)
- …job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position will report to the Director, Engineering, ... production, utility systems and associated infrastructure.- Responsibilities of the Specialist - Manufacturing Automation include the following:Site Operations (GWES)… 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 ... records, reports) associated with technical operations, production, engineering, and validation Incorporate technical pre-planned process improvements and cost reduction… 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. (Plainsboro, NJ)
- …membership work instructions and procedures Verify contract membership data testing and validation with IT is properly performed Work with Chargeback personnel to ... research and adjudicate membership discrepancies Physical Requirements 0-10% overnight travel required. Qualifications A Bachelors degree or equivalent experience required Familiar with enterprise-wide integrated application systems such as SAP, Model N, or… 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 and ... reporting/trending Reviews manufacturing and support records to certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk through audits of the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Possess signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports ... Participates in Regulatory Inspections Other duties as assigned Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes Incorporates the Novo Nordisk… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …part of the Technical Operation team and will be responsible to provide specialist knowledge and expertise of cell and gene therapy processes and/or process ... manufacturing technologies. Ensure successful manufacturing process comparability and process validation runs by assessing risk, establishing preventative measures, investigating,… 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: + ... Sciences and the following years of relevant experience for each level: + Associate QA Validation Specialist : 0 - 2 years + QA Validation Specialist : 2+… 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: + ... Sciences and the following years of relevant experience for each level: + Assoc. QA Validation Specialist : 0 - 2 years + QA Validation Specialist : 2+… more
- PCI Pharma Services (Philadelphia, PA)
- …duties and responsibilities include the following but other duties may be assigned. A Validation Specialist is expected to lead the business beyond the normal ... opportunities within existing business or customer requests Standardization/harmonization/streamlining of validation activities. A Validation Specialist will… 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 ... teams, including developing and reviewing protocols and final reports, representing validation on project teams, and preparing validation change control… more
- Charles River Laboratories (Wayne, PA)
- Computer Systems Validation Specialist Req ID #: 223070 Location: Wayne, PA, US, 19087 For 75 years, Charles River employees have worked together to assist in ... can feel passionate about. **Job Summary** Responsible for computerized system validation activities within CRL Manufacturing Operations, including, but not limited… 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
- 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 ... Your role Reporting to the Senior Manager, Engineering, JOB SUMMARY: Manages validation projects or multiple validation project activities under limited… more
