- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Quality Engineer is responsible for overseeing the health of the manufacturing processes. This starts with proper risk analysis in manufacturing ... system to ensure the root cause is identified and controlled. The Quality Engineer will work collaboratively with the Engineering and Production departments. A key… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Senior Controls Engineer will be responsible for installing, modifying, and servicing process control systems throughout the facility as well as ... processes as well as providing electrical engineering. The Sr. Controls Engineer will utilize data management skills, PLC (Programmable Logic Control) skills,… more
- Aequor (Framingham, MA)
- …file new product and process life cycle improvements. KEY RESPONSIBILITIES The Process Engineer IV role is expected to Provide technical leadership in area of ... results; recommend changes or additional experiments. Support documentation preparation for regulatory purposes and stay current on regulatory requirements that… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ. Role ... OverviewThe MES Engineer will be part of Manufacturing Excellence team reporting...the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible for the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …procedures with some latitude to change work processes and workflow. Automation Engineer will perform PLC Programming for brownfield projects with our existing ... (5) year of direct engineering Pharmaceutical, Biotechnology or other regulatory industries experience preferred Knowledge, Skills, and Abilities: Strong knowledge… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of BMS users Develop and implement project(s) under the support of Sr. Engineer or external consultants as appropriate to maintain the BMS system throughout the ... component and software lifecycle Provide input during regulatory inspections of BMS and relevant projects as needed Work with the project manager to coordinate the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Controls Engineer is responsible for installing, modifying, and servicing process control systems throughout the facility as well as providing ... and control schematics while ensuring compliance with safety and regulatory standardsProvide technical support for system commissioning, start-ups, and ongoing… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Engineer , Network Automation will be responsible for installing, maintaining, and troubleshooting the networking systems for automated utility, ... ISO, EU and ICH.Understand 21 CFR Part 11, cGAMP, and other regulatory guidance associated with computer / automation-based systemsAuto CAD and networking experience… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- As a Sr Utilities Engineer (Clean Utilities), you will provide cross-functional support to operations, maintenance, quality and project teams for site GMP utilities. ... is maintained to meet GMP requirements.Support utilities areas in Regulatory / FDA inspections ensuring successful outcomes.Cross functional collaboration with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to ensure they operate as per the design intent and meet regulatory standards.Collaborate with mechanical engineers and contractors to ensure HVAC equipment is ... installed correctly and meets specifications.Perform regular audits of HVAC systems to identify opportunities for energy conservation or operational improvements.Design, program, and configure Tridium Niagara N4 systems for building automation.Interface with… more
