- Merck & Co. (Rahway, NJ)
- …challenges and influence across the enterprisePreferred Experience and Skills: Project management, including change control and equipment qualificationSAP ... Requests, People Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management, Regulatory Compliance, Regulatory… 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...Lead and/or Management on daily progressAbility to contribute to project teamsFocus and attention to detail is criticalWorking knowledge… more
- Merck & Co. (Durham, NC)
- …in problem solving and troubleshooting Preferred Experience and Skills: Project management, including change control and equipment qualificationSAP ... experience related to plant maintenance and spare parts procurement systemscGMP experience in a sterile, bulk or finished pharmaceutical environmentExperience in automation and manufacturing execution systems (MES), process modeling and process… more
- Aequor (Thousand Oaks, CA)
- …such as Monte Carlo simulations Familiar with utilizing GitLab for version control , code collaboration, and project management Data analysis expertise and ... to deliver work and provide positive leadership in a fast-paced, multi- project team-oriented environment Intellectual curiosity with ability to learn new… more
- Merck & Co. (Durham, NC)
- …safety, quality and process enhancements throughout the supply chain - Project Management Lead and sponsor all Supply Chain Logistics initiatives surrounding ... (SOP) to align to SAP and business processes related to any new project implementations.Site supply chain lead and coordinator for the successful implementation of… more
- Merck & Co. (Rahway, NJ)
- …and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence ... the established requirements.Represent Device Development & Technology and the project -specific Combination Product Working Groups on cross-functional teams at the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(PV) oversight. This role fulfills the PV Oversight function in PV quality control processes, as well as providing SME-level input from the affiliate perspective ... Time' mindset to effectively perform quality assessments and deliver quality control on identified areas of focus within external pharmacovigilance (PV) partners… more
- Merck & Co. (Rahway, NJ)
- …will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing ... all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or… more
- Aequor (Thousand Oaks, CA)
- …at ATO B20. The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20 with a ... Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading… more
- Novo Nordisk Inc. (Durham, NC)
- …machine learning for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using predictive ... from wide variety of data sources Support manufacturing, business, and project departments with process understanding, analyses, and systematic problem solving… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …related projects. He/she will work with Planners, Manufacturing, Facilities, Quality Control , MSAT, and Engineering to support and improve the planning processes ... partner with PAS-X, SAP, OMP and shop floor planning project teams on master data and system adoption Analyze...maintain site capacity data, future state objectives, and schedule control Implement LEAN & flow in the plant, proactively,… more
- Merck & Co. (Rahway, NJ)
- …to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution.Conceptualize, plan, and execute ... BPR&D as a upstream bioprocess expert/co-leader in internal and cross-functional project teams.Supervise, coach, and develop talent within the functional area; guide… more
- Merck & Co. (Rahway, NJ)
- …be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination ... clear communication to cross-functional stakeholders, including external suppliers.-Proactively resolve project obstacles and challenges and communicate device development strategy… more
- Twist BioScience (South San Francisco, CA)
- …core teams. Collaborates with team members to develop detailed project plans. Coordinates activities across multiple functional groups including Product ... Management, R&D, tech transfer, manufacturing, and QC/QA.Leads and facilitates project meetings with an efficient and structured approach to ensure successful… more
- Merck & Co. (Durham, NC)
- …opportunity for a Specialist to join the operations team supporting a capital project critical to Human Health at our facilities in Durham, North Carolina. This ... drug product, including product inspection, warehouse, utilities, and quality control laboratories.The Specialist, Operations will be responsible for providing… more
- Merck & Co. (Durham, NC)
- …member of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual ... will be-responsible for problem resolution, implementation of process control , data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety,… more
- Merck & Co. (Rahway, NJ)
- …inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter expert. Proactively identify, execute ... Auditing, Interpersonal Relationships, Management Process, Manufacturing Processes, Manufacturing Quality Control , Process Improvements, Quality Assurance (QA), Quality Assurance Systems,… more
- Merck & Co. (Austin, TX)
- …and REST APIs.Participate in test planning, safety validation, change control , and rollback design.Document technical implementations, integration patterns, and ... engineering, IT automation, or platform integration; candidates with strong project -based or adjacent technical experience will be consideredExperience with at… more
- Twist BioScience (South San Francisco, CA)
- …adoption, effective GxP training programs, and adherence to change control procedures for custom software releases.QualificationsBachelor's degree in Computer ... fermentation, purification, aseptic filling, media/buffer prep, etc.) and associated automation/ control systems (SCADA, DCS, PLC, HMI) from a software integration… more
- Merck & Co. (Durham, NC)
- …recommending spare parts, selecting lubrication processes and assisting process project engineers.Assists with execution of automation, validation and additional ... and safe maintenance and repair of equipment using Hazardous Energy Control Procedures (HECPs)Compliance with current good manufacturing procedures(cGMP), safety and… more
