- Merck & Co. (Durham, NC)
- …License:NoHazardous Material(s):N/ARequired Skills:Adaptability, Adaptability, Biodesign, Capital Projects, Change Control Management, Chemical Engineering ... filings including technical reports and risk assessments Author or approve Change Control documentation for complex process, validation, analytical, equipment,… more
- Merck & Co. (Rahway, NJ)
- …role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical ... its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the… more
- Merck & Co. (Durham, NC)
- …SAP transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an ... so, then this is the opportunity for you! The Lead Tech, Engineering is a member of...service and operational challengesQuality & Safety Compliance:Develop and execute engineering change request (ECRs), as necessary.The successful… more
- BioAgilytix (Durham, NC)
- …checks, and setting up clear governance so everyone knows who can see or change each dataset. You'll start as a "player-coach," doing the technical heavy lifting ... governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes,… more
- Sanmina-SCI (San Jose, CA)
- …Ability to work independently and as part of a team Experience with the Engineering Change Control process and Deviations Process Familiarity with IQ/OQ/PQ ... Electronics Manufacturing Services (EMS) market. Recognized as a technology leader , Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior… more
- Merck & Co. (Durham, NC)
- …Our company in the United States and Canada, is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health ... the Vaccine Manufacturing facility in Durham NC, the Supply Chain Logistics Strategy Leader will be responsible for the development, management, and growth of our… more
- Novo Nordisk Inc. (Durham, NC)
- …within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change management Lead ... Support Corporate, PS AM, local IT, & local stakeholder initiatives & projects Lead the team's Change Management standards and always manage assignments within… more
- US Engineering (Wichita, KS)
- US Engineering has been an industry leader ...workplace where even our newest team members can influence change and make an impact. We know that our ... replaces parts that are defective. Repairs refrigeration, air conditioning, heating, control systems, and humidity and temperature control systems. Troubleshoot… more
- Twist BioScience (South San Francisco, CA)
- …for both internal development and external services, and demonstrating ROI for MES investments. Change Management: Lead change management efforts related to ... ensuring user adoption, effective GxP training programs, and adherence to change control procedures for custom software releases.QualificationsBachelor's degree… more
- Aequor (Thousand Oaks, CA)
- …and Vial/Syringe Filling operations Experience with various quality systems including change control , deviations, corrective and preventative actions, and/or ... This "Specialist Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital… more
- Eisai, Inc (Exton, PA)
- …deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control , and corrective and preventive actions.6. Oversee ... and close-out of documentation, manufacture of DS/ADI materials, and suite change -over ensuring compliance to relevant regulations. The Associate Director is also… more
- Merck & Co. (Durham, NC)
- …Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply Chain Management:-Manage coordination with ... : Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and...and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Therapy cGMP manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES ... within the organization.RequirementsA minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced...solving and critical thinking skills and the ability to lead as a change agent to promote… more
- Novo Nordisk Inc. (Durham, NC)
- …advanced cLEAN® tools within the main areas of problem solving, project & change management. Lead cross-functional process improvements. Develop plans to improve ... to Manager, Technical Support. Essential Functions Coach & mentor peers, Engineering personnel & Process Maintenance Technicians. Support technical development of… more
- Also, Inc (Palo Alto, CA)
- …preferred) and PLM systems for propulsion component design, including BOM structuring and engineering change control . Strong mechanical engineering ... performance while ensuring manufacturability and cost-effectiveness for EV applications. Lead engineering decisions on winding technologies, magnet materials,… more
- Amazon (Reading, MA)
- …in partnering with contract manufacturer with NRTL factory inspections - Experience in engineering change control processes (Agile) - Experience in ... industrial robot systems in national and international markets. This position will lead new and existing product development work related to regulatory compliance… more
- USAA (Phoenix, AZ)
- …procedures/process, accurate regulatory reporting and filing, document governance, risk control self-assessments, procedure governance, control design, new ... between dependent processes to minimize failures, eliminate redundancies, and control process performance necessary to achieve efficient, effective design and… more
- Vertiv Group Corp. (Westerville, OH)
- …maintenance and troubleshooting procedures. Act as the Vertiv Services representative on the engineering change control board. Provide technical expertise in ... team. RESPONSIBILITIES New Product Development Projects Interface with R&D engineering and product management to implement the Global Serviceability Specification… more
- Johnson Health Tech Companies (Vancouver, WA)
- …and corrective action if products do not meet requirements. *Direct experience with Engineering Change Management and documentation control in a ... Engineering teams to drive vendor compliance, product testing, and effective engineering change management across the supply chain. The Director of Vendor… more
- HDR (San Diego, CA)
- …Each and every role throughout our organization makes a difference in our ability to change the world for the better. Read further to learn how you could help make ... the world. In the role of Power Market Sector Leader , we'll count on you to: Have a focus...opportunities for staff growth and development They will also lead and/or assist with the identification and recruitment of… more
