- Merck & Co. (Rahway, NJ)
- …and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings and equipment ... Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily… more
- Merck & Co. (Durham, NC)
- …timelines. Lead aspects of regulatory inspections by presenting and defending technical documentation , investigations, and change controls Evaluate and develop ... in vaccine or biologics manufacturing within a cGMP environment Experience authoring technical documentation within a cGMP context Proven leader with influence… more
- Merck & Co. (Rahway, NJ)
- …teams to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation , ensuring all processes align with our company's ... you will:Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization,… more
- Merck & Co. (Rahway, NJ)
- …(TT), scale-down model qualification (SDMQ) and process characterization (PC).Experience authoring technical documentation in support of the following: process ... Job DescriptionWe are seeking a strategic and technical leader with expertise in cell culture commercialization. The primary objective of the Biologics Drug… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …developers and is tasked with providing strategy and vision on the technical implementation, optimization, and deployment of AI/ML pipelines, AI/GenAI models and ... that: Attracts and cultivates essential skills needed for data & AI Engineering , GenAI development, and analytics automation and dashboarding, ensuring the team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …outside established processes.RequirementsA minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline or relevant experience is ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role… more
- Repligen (Rancho Dominguez, CA)
- …with industry standards and regulations. Develop and maintain engineering documentation including test protocols, change controls, and technical reports. ... device manufacturing, with deep expertise in Tangential Flow Filtration (TFF) systems , process engineering , and equipment qualification, preferably within GMP… more
- Aequor (Thousand Oaks, CA)
- …and specifications from the analysis of measured data Strong communication, presentation, and technical documentation skills are a plus, as is knowledge of ... proficient in Python, MATLAB, and Minitab, and possess a deep understanding of engineering principles applied to physical systems . The candidate holds either a… more
- Merck & Co. (Rahway, NJ)
- …and system design for workflow management is an asset.Strong aptitude for authoring Technical Guidance documentation such as User Guidance and Standard Operating ... Min. Requirement: BS/BA or an equivalent certification/experience in science, engineering , IT or related discipline with functional working experience in… more
- Merck & Co. (Rahway, NJ)
- …assembly equipment integrated processes such as ultrasonic welding and vision inspection systems .Author technical content of assembly process FMEAs to capture ... clinical and commercial assembly equipment and processes for medical devices/drug delivery systems . Reporting to the Director responsible for this area, you will… more
- BioAgilytix (Durham, NC)
- …data governance platforms (eg, Collibra, Alation).Demonstrated experience as a self-directed technical contributor with hands-on expertise in data engineering , ... can see or change each dataset. You'll start as a "player-coach," doing the technical heavy lifting yourself while laying out the roadmap for a future team.Just as… more
- Aequor (Thousand Oaks, CA)
- …alignment and knowledge transfer. Drive the development of clear and concise technical and procedural documentation , leveraging strong technical writing ... in a regulated industry (biotech, pharma, etc.). Proven experience with GMP documentation and technical writing. Strong understanding of supply chain and… more
- Merck & Co. (Upper Gwynedd, PA)
- …of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.Lead the ... transition to the Post-Approval Pharm CMC team.Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the Manufacturing Engineering department on cross-functional teams (Manufacturing, Engineering , Technical Support and Quality groups) Performs all job ... (Downstream) Essential Functions Assist with coordinating fabrication, procurement, installation, engineering start-up, verification and validation activities of new equipment… more
- Twist BioScience (South San Francisco, CA)
- …releases.QualificationsBachelor's degree in Computer Science, Software Engineering , Electrical Engineering , or a related technical field. Master's degree ... integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with… more
- Formation Bio (New York, NY)
- …use cases.This position sits at the intersection of healthcare data engineering , modern data platform infrastructure, and generative AI. While your initial ... governed, and high-reliability pipelines.The ideal candidate combines deep data engineering experience with both GenAI fluency (eg, LLM-based entity extraction,… more
- Merck & Co. (Durham, NC)
- … engineering groups.- Supports a spectrum of sophisticated automated systems within Manufacturing Operations; providing multiple opportunities to learn new ... of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual will… more
- Aequor (Thousand Oaks, CA)
- …as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI Lead is expected to ... network: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering . A high degree of interactions and collaboration is required across… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … engineering start-up, and validation activities of new equipment and systems , including documentation of IQ/OQ protocols, test executions, and summary ... interactions with others Qualifications Education and Certifications Bachelor's degree in an engineering or technical discipline required; Master's degree in … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …test Plans (CTP), Installation/Operational Qualification (IOQ).Define standardizations and update documentation (eg SOPs, WIs, Technical & Design Specifications, ... will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at… more
