- Insmed Incorporated (San Diego, CA)
- …material specifications, protocols and author development reports.Demonstrated experience with process validation and scale-down models for biopharmaceutical ... Medium Workplaces™ lists.OverviewWe are seeking a highly motivated expert in purification process development of viral vector gene therapy products. In this role you… more
- Repligen (Rancho Dominguez, CA)
- …bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation , and facility upgrades. Conceives, plans, and executes ... is highly desirable. Hands-on experience with: Tangential Flow Filtration (TFF) Process validation and equipment qualification Tech transfer between sites… more
- Merck & Co. (Rahway, NJ)
- …of product design and development, manufacturing process development, qualification, validation , and design control and risk management techniques to ... requirement management, design verification, automation/ process development, design validation , human factors evaluations and control strategy.Deep and… more
- Merck & Co. (Durham, NC)
- …vendors and recommending spare parts, selecting lubrication processes and assisting process project engineers.Assists with execution of automation, validation ... and patients on time, every time, across the globe. The Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance… more
- Merck & Co. (Durham, NC)
- …vendors and recommending spare parts, selecting lubrication processes and assisting process project engineers.Assists with execution of automation, validation ... manufacturer? If so, then this is the opportunity for you! The Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and ... guidance, performs analytical method validations and release/stability raw materials, in process (IP), finished products (FP) and stability (ST) samples for pilot… more
- Twist BioScience (South San Francisco, CA)
- …custom software and CSV.Experience with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom ... Sr . Director, Manufacturing Execution System (MES) (Hybrid in...requirements gathering, system design, coding standards, development, rigorous testing, validation , deployment, and post-go-live support for new and existing… more
- Merck & Co. (Rahway, NJ)
- …on their expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will ... experience to develop safe and robust manufacturing processes through process characterization, technology transfer, validation , filing and supply… more
- Merck & Co. (Rahway, NJ)
- …with device design, requirement management, FMEA, design verification, design validation , statistical sampling, and control strategyExperience with regulatory ... DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls (Associate Director Equivalent) Our company's Device Development & Technology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …combined experience in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management… more
- Merck & Co. (Rahway, NJ)
- …to capture patient and process risk and identify appropriate in- process controls to ensure robust and efficient throughput.Develop characterization plans ... Job DescriptionAs a Senior Engineer in Device Design and Process...equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.Understanding of autoinjector/parenteral/pre-filled… more
- ACROBiosystems Inc. (New York, NY)
- …support drug development and clinical applications from target discovery and validation , candidate drug screening and optimization, CMC development, preclinical and ... to excellence in providing quality products and services and accelerating the process of therapeutic development. Our mission is to accelerate the process… more
- Merck & Co. (Rahway, NJ)
- …techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related ... Immunoassays, Immunochemistry, Innovation, Laboratory Informatics, Liquid Chromatography (LC), Management Process , Matrix Management, Mentoring Staff, Method Validation … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external network for primary intelligence gathering and cross- validation . Oversee development of presentations with clear storylines to communicate ... key conclusions and recommendations to Sr . Leadership. Modernize insight sharing to ensure NNI continues...are well aligned and integrated into North American planning process , including any associated work streams. Ensure self and… more
- Aequor (Thousand Oaks, CA)
- …Filling operations Experience with various quality systems including change control , deviations, corrective and preventative actions, and/or validation ... that enable the B20 plant to add value to the network: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. A high degree of… more
- Danaher Corporation (Fargo, ND)
- …stakeholders on test method validation , including method transfers, client-specific validation activities, and process validation . Represent the ... You will be a part of the Analytical Method Validation Team and report to the Sr ....manner. Aldevron is seeking a highly skilled and experienced Senior Scientist to join our Analytical Method Validation… more
- PCI Pharma Services (Rockford, IL)
- …global network to pioneer and shape the future of PCI. **Job Title: Senior Validation Engineer - Medical Device Assembly (CDMO)** **Location:** [Rockford] ... Quality **Position Summary:** We are seeking a highly skilled ** Senior Validation Engineer** to support the ...+ Six Sigma certification or formal training in statistical process control (SPC). **For candidates in Illinois:**… more
- Cardinal Health (Indianapolis, IN)
- …Medical Device). + Experience with equipment qualification, software validation , test method validation , and/or process validation . + Validation and ... Quality Engineering manages product and service quality planning, evaluation and control . This job family works cross-functionally in the development and… more
- Abeona (Cleveland, OH)
- …Provides facility, equipment and process qualification technical expertise. Author validation documents and execute validations of equipment, control systems ... The Sr . Validation Engineer will provide specialized...+ 8+ years of experience in an Equipment and/or Process Validation Engineering role within a pharmaceutical… more
- Actalent (Elwood, KS)
- …environments. + Expertise in validation testing and protocols. + Knowledge in process validation and equipment validation . + Excellent technical writing ... utilities, and processes. This position requires consulting with site technical services for process and cleaning validation , while reporting to the Director of… more
