- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …performance indicators and participates in SDLC Lessons Learned sessions to evaluate validation process improvements and efficiencies and measure key success ... rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… more
- Catalent (St. Petersburg, FL)
- …b) process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all Preventive ... trend analysis to eliminate future problems. Participates in Product Development/ Validation /Engineering project meetings to provide Quality Assurance input with… more
- Careerbuilder-US (Spencer, IN)
- …start to finish. Practical aptitude in fixture design, test method validations, process characterization and process validation including operator ... Job Title: Process Development Engineer Location: Spencer, IN 47460 Duration:...design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal and clinical studies),… more
- Careerbuilder-US (San Diego, CA)
- …manufacturing processes for transfer to Manufacturing. * Assists with execution of process validation of new and existing manufacturing processes. * Trains ... Job Title: Process Development Associate Location: San Diego, CA Duration: 6+ months Pay range is: $28.50/hr . on W2 Job Description: First Shift Monday through… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with the Validation Department to participate and provide feedback to NN validation process group Ability to work and communicate effectively across multiple ... and inspections Maintains technical knowledge and current trends within the commissioning process and science and risk-based validation (SRV) programs Other job… more
- Lundbeck (Bothell, WA)
- …and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team.The Lu-SBP team leads and supports ... Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global… more
- Aequor (Bothell, WA)
- …through design reviews and user acceptance testing during the development and validation process . Perform and communicate planning, development, peer review, and ... another MES system will be considered. Experience with writing and executing validation protocols. PURPOSE AND SCOPE OF POSITION (Position Summary):The MES Recipe… more
- Catalent (St. Petersburg, FL)
- …II, AR&D and AR&D department provides analytical services to manufacturing, process development, validation , and new material qualifications. AR&D interacts ... patient, consumer and Catalent employee.The RoleAnalysis of finished products, in- process materials, fill moisture, raw materials, and cleaning verification and… more
- Aequor (Thousand Oaks, CA)
- …or oversee the following functions: a) Review and approve product MPsb) Approve process validation protocols and reports for Mfg. processes. c) Approve ... and experience with processes involved in manufacturing and distribution, QA, QAL, validation , and process development. Strong communication (both written and… more
- Nesco Resource (Cambridge, MA)
- …the production of medical capital equipment and components. Demonstrated ability in process validation , design transfer, and working with sterilizable polymers ... techniques. Proficiency in applying DFM, Six Sigma, LEAN, cGMP, and process validation principles. Skilled in using Microsoft Office Suite and statistical tools… more
- DivIHN Integration Inc (Marion, NC)
- … process optimization and automation, VIP identification and implementation, process validation planning\execution using lean manufacturing techniques and ... regulatory compliance issues. Writes and/or executes, and reports on validation activities. Designs and performs routine testing, project experiments, analysis… more
- CMJobPoster (Temecula, CA)
- …following experience: Manufacturing of medical devices is a MUST HAVE Equipment & process qualification Process validation activities Change orders Problem ... for task approach direction as well as peer review of verification/ validation activities. Bachelor Science or Bachelor Engineering, Electrical, Software, or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … improvement and implementation of new manufacturing technologies. Ensure successful manufacturing process comparability and process validation runs by ... specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. They will also oversee processes and standards to maintain and… more
- Catalent (St. Petersburg, FL)
- …demonstration/feasibility batches, registration/stability batches, and technical support of process validation batches. Additional responsibilities may include ... successful timely development of new pharmaceutical products utilizing Softgel Formulation/ Process drug delivery systems and technologies by carrying out required… more
- Catalent (St. Petersburg, FL)
- …scale, demonstration/feasibility batches, registration/stability batches, and technical support of process validation batches. Catalent is committed to a ... successful timely development of new pharmaceutical products utilizing Softgel Formulation/ Process drug delivery systems and technologies by carrying out required… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …routine manufacturing and protocol driven activities such as tech transfer and process validation Provides guidance on industry best practices, and quality ... position with responsibilities for providing quality oversight for the manufacturing process , equipment, and associated deviations and investigations within a cell… more
- Nesco Resource (Plymouth, MN)
- …ergonomic improvements.Assists in the commissioning of new production equipment, including process validation efforts.Assists in the development and testing of ... external complaints. In addition, prepares protocols and reports to perform validation and qualification testing on product and processes. Responsible to properly… more
- Medline Industries LP (Northfield, IL)
- …21 CFR 210/211). Experience with ISO 13485. Experience applying knowledge of process validation , method validation and sterilization processes. Experience ... with excellent oral and written communication skills. Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing… more
- Aerojet Rocketdyne (Orange, VA)
- …Title III efforts to accelerate site development, program optimization, and equipment/ process validation of fielded tactical rocket programs transitioning to ... the preparation and maintenance of detailed operations/manufacturing documentation such as: process hazards/job safety analyses, process flow diagrams and… more
- Rose International (Newton, MA)
- …building, and testing complex electro-mechanical medical devices, design transfer, and process validation with broad knowledge of mechanical, mechatronics, ... test and build fixtures Author relevant documents such as build process , assembly instructions, inspection procedures, test protocols, test reports, analyses, and… more
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