- Merck & Co. (Durham, NC)
- …CMMS system platforms and route engineering change requests through CMMS system .Expand knowledge into other systems , capable of managing change in the ... related projects by planning path forward for least disruption to plant operationsCoordinates maintenance activities which require external vendors for shipment and… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality… more
- Aequor (Thousand Oaks, CA)
- …will be responsible for the introduction of new products into the manufacturing plant . This "Specialist Manufacturing" role will serve as a New Product Introduction ... Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI...between the 5 key functions that enable the B20 plant to add value to the network: Manufacturing, Process… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... such as boilers, chillers, Cooling towers, air compressors, waste deactivation systems , HVAC, clean steam, WFI.- Develops Standard Operating Procedures (SOPs) and… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Process Equipment (eg Filling Machine,… more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Merck & Co. (Durham, NC)
- …Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality ... monitoring during processing and records results in the computerized database system . Provides timely delivery of samples and other materials as required… more
- Eisai, Inc (Exton, PA)
- …lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting technology transfer to external partners (as ... upstream and downstream production suites in a cGMP biopharmaceutical pilot plant , including scheduling of staff, preparation and close-out of documentation,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with direct/indirect referral: n/a Essential Functions Perform preventive maintenance (PM) of plant Respond to and rectify alarm conditions on plant equipment ... Develop and maintain a working knowledge of building and process automation systems (BMS and PCS) Interfaces with engineering and/or manufacturing departments to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …, computer systems , and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. ... protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide… more
- Merck & Co. (Durham, NC)
- …Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality ... Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved vendors for calibrations not performed by site… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …subordinates with direct/indirect referral: N/A Essential Functions Update data in planning systems such as SAP, OMP, and RTMSto ensure integrity Assist with ... shop floor planning project teams on master data and system adoption Analyze and apply resolutions for material availability,...and schedule control Implement LEAN & flow in the plant , proactively, show a LEAN mindset Interface with Production,… more
- Repligen (Rancho Dominguez, CA)
- …device manufacturing, with deep expertise in Tangential Flow Filtration (TFF) systems , process engineering, and equipment qualification, preferably within GMP or ISO ... as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation, and facility… more
- Aequor (Hicksville, OH)
- …the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant , and Corporate quality and Behavioral Based Safety (BBS) goals. Note: ... of pharmaceutical products. Basic knowledge of computer applications, including SHAPE system and Microsoft Office. Proficient in basic level arithmetic. Working… more
- Aequor (Walkersville, MD)
- …paperwork and logbooks for the department Quality Responsibility Maintenance of quality systems and cGMP compliance for the business by ensuring that all team ... of the work is done in a laboratory environment. Scrubs, hairnet and plant dedicated shoes are required to work in unclassified areas. Working conditions can… more
- Merck & Co. (Durham, NC)
- …and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director).-This role ... serves as a Virtual Plant Manager - responsible for leading a cross-functional team...a strong interdependent relationship with External Partner Site and Plant Leadership Team. Create and maintain an inclusive culture… more
- Aequor (Thousand Oaks, CA)
- …be considered. This position supports 's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing ... in the execution of their processes, procedures, and use of quality systems . Duties include purposeful presence on the floor, electronic batch record review,… more
- Merck & Co. (San Francisco, CA)
- …and plant modeling.General understanding of data sources and IT systems (eg, Signals, Analytical Instrument data, Spotfire, Thoughtspot, data lakes, dashboards, ... data models, etc.).Proficiency in portfolio management software such as Planisware, MS Planner/Dynamics 365, etc. Understanding of emerging technologies and digital tools that can be applied to project management (agentic AI, LLMs, etc)Demonstrated ability to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …start-up, verification and validation activities of new equipment and systems . Responsibilities include verification protocol execution (FAT, SAT, DQ, Commissioning, ... improvement changes Participate in design and hazard reviews of plant expansions or process changes and serving as the...well as the continued operation of such facilities Ensures systems and processes are verified and validated in a… more
- Tris Pharma (Monmouth Junction, NJ)
- …as neededPrecisely follows work orders and specificationsAdheres to all plant safety policies and proceduresRequirementsRequirements Minimum education and years of ... pertaining to manufacturing processes Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPsAnticipated… more
