- Repligen (Rancho Dominguez, CA)
- …Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation, and ... are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and ... requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according… more
- Merck & Co. (Rahway, NJ)
- …syringes, and complex drug delivery systems .Proven expertise in design controls , risk analysis, control strategies, design verification testing, and process ... products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical… more
- Merck & Co. (Rahway, NJ)
- …and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work ... and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control /QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am EST - ... 4:30 pm EST.The Document Control /QA Associate I will report directly to the QA/QC...to meet established deadlines (paper and electronic).Maintains related database systems , if applicable, logs and complete forms/records as required.Adheres… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Lead Maintenance Technician is responsible for providing equipment troubleshooting and maintenance ... MachinesThe ability to satisfactorily perform all types of industrial mechanical work as assigned. Lead the shift group of mechanics and serves as a role model within… more
- BioAgilytix (Durham, NC)
- …governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes, ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… more
- Twist BioScience (South San Francisco, CA)
- …a proven ability to scale accounting operations, and the determination to lead the department through growth and continuous improvement.Position is Hybrid - Tuesday, ... support strategic initiatives by establishing the proper general ledger structure and controls for investments in new products and servicesEnsure proper oversight of… more
- Aequor (Davie, FL)
- …:1. Electrical field degree with a minimum of 2 years working with electrical systems (24v - 480V) and utilities (HVAC, Boilers, water systems , cooling towers, ... The position will function as a subject matter expert for electrical systems and installations.Also in equipment maintenance, trouble shooting and repair. It… more
- Aequor (Thousand Oaks, CA)
- …a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI Lead is expected ... Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control , deviations, corrective and preventative… more
- Novo Nordisk Inc. (Durham, NC)
- …in relevant areas Own self development & initiative to understand the site process control systems , data management systems , and differing data sources (PCS, ... Team Novo Nordisk and help us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and… more
- Twist BioScience (South San Francisco, CA)
- …culture, fermentation, purification, aseptic filling, media/buffer prep, etc.) and associated automation/ control systems (SCADA, DCS, PLC, HMI) from a software ... experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom,… more
- Repligen (Clifton Park, NY)
- …linear motion, cartesian motion (ie, pick & place, measurement, load, and unload). Controls - vision systems , PLC, sensors, pneumatics, hydraulics, electronics, ... single-use state-of-the-art single use components and innovative storage and transfer systems that optimize fluid transfer and reduces the number of connections… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of IT security strategy and serving as a security advisor to ensure IT systems are implemented and maintained to the highest security standards. Individuals in this ... and application level. Some responsibilities developing and implementing security controls and formulating operational risk mitigations. Relationships: Reports directly… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... to: - - Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and… more
- Formation Bio (New York, NY)
- …for a builder who thrives on technical depth, mentorship, and platform thinking. You'll lead the design of scalable systems that transform both structured and ... infrastructure at the intersection of data engineering and applied AI. You'll lead efforts to ingest and transform unstructured and structured research, biomedical… more
- Merck & Co. (Rahway, NJ)
- …Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products ... reality.What You'll Do:As a key player in our BDSC team, you will: Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on… more
- Merck & Co. (Rahway, NJ)
- …its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the ... on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality, and innovation of the credit union's payments ... for performance, member experience, and operational efficiency.Risk & ComplianceMaintain strong controls and procedures to comply with all applicable laws and… more
