- Eisai, Inc (Nutley, NJ)
- …functions and compliance controls .Monitor and test IT compliance controls for effectiveness.Remediate control deficiencies and investigate potential unlawful ... program, including JSOX compliance.Maintain accurate compliance documentation and advise control owners.Assess risk , evidence adequacy, and remediate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensuring accountability of team members for deliverables. Additionally, the Risk Assessment lead will communicate across functional and leadership ... risk , evaluate the risks and work resources to control the risks based on failure analysis results. Plan...and implement and manage change when necessary to meet risk assessment outputs. Lead issue oriented … more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Lead Maintenance Technician is a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in ... supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. The … more
- Merck & Co. (Rahway, NJ)
- …a roadmap to deliver greater business value and maintain a secure and modern technology landscape. Lead a team of developers to manage the application stack and ... are looking for an energetic, self-starter to join our Enterprise Information Technology team to help us identify and deliver business solutions, in partnership… more
- Merck & Co. (Rahway, NJ)
- …a roadmap to deliver greater business value and maintain a secure and modern technology landscape. Lead a team of developers to manage the application stack and ... are looking for an energetic, self-starter to join our Enterprise Information Technology team to help us identify and deliver business solutions, in partnership… more
- Eisai, Inc (Nutley, NJ)
- …standards.Experience in implementing and maintaining robust cybersecurity practices, including risk management, access controls , network security, and ... involves collaborating with other Eisai regions and global Enterprise Information Technology teams, contributing to the global infrastructure strategy design and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and ... in the treatment of multiple myeloma. Legend Biotech is seeking a QA Investigations Lead (2nd or 3rd shift) as part of the Quality team based in Raritan,… more
- Merck & Co. (Rahway, NJ)
- …tech transfer processes and procedures (internal and external).Working knowledge of design controls and risk management processes for medical devices and ... in medical device and combination product design verification, the candidate will lead the strategy and execution of design verification activities from concept to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and ... own the process knowledge of the cell and gene therapy manufacturing process technology to support technical activities for transfers into and out of the Raritan… more
- Merck & Co. (Durham, NC)
- …Project coordination leadership and implementation of troubleshooting activities and change control . Initiate and lead collaboration within the Operations, ... member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.As an… more
- Merck & Co. (Rahway, NJ)
- …overall plan and country specific needs and priorities.- Enhance Governance and Control Processes : The Director is responsible for creating internal and external ... control through governance and audit processes.- They will collaborate...and procedures to further enhance governance as well as lead in any process failure events to conduct thorough… more
- Merck & Co. (Durham, NC)
- …and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key automation-related ... responsibility.Support digital innovation initiatives on an as-needed basis.Initiate and lead collaboration within the Operations, Quality, and Technical organizations… more
- Merck & Co. (Durham, NC)
- …inclusive team culture including significant interaction with Operations, Quality, Automation, Technology , and other groups as required. Primary activities for this ... on time approval of payroll activities using site approved software like ADP. Lead and support daily meetings to facilitate flow of information up/down through… more
- Tris Pharma (Monmouth Junction, NJ)
- …spanning neuroscience and other therapeutic categories employing our proprietary science and technology . Our science and technology make us unique, but it ... Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... team culture including significant interaction with Operations, Quality, Automation, Technology , and other groups as required.The Lab Senior Maintenance Technician… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... products. Lead the validation team in the establishment and maintenance...in the establishment and maintenance of validated systems. Coordinate technology transfer activities in support of commercialization. Serve as… more
- Merck & Co. (Durham, NC)
- …validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an inclusive team ... culture including significant interaction with operations, quality, automation, technology , and other groups as required. GENERAL PROFILE: Ability to perform routine… more
- Merck & Co. (Rahway, NJ)
- …The Specialist - Manufacturing Automation position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team at the ... Organics Pilot Plant (SSO): - The SSO uses an Emerson DeltaV Distributed Control System.- The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in… more
- Merck & Co. (Durham, NC)
- …with constituent groups include but not limited to internal customers (operations, technology and labs)Applies understanding and is able to anticipate the needs of ... of atypical events including accessing product impact for events.Ensure proper control of materials via product investigationsAssist regulatory groups by providing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …IT Security and other SMEs in IT/OT to implement and maintain appropriate controls and technologies to ensure business continuity Train other staff and stakeholders, ... work package owner on IT Infrastructure related projects and lead internal and external team working as part of...about risks and how to handle/mitigate them, taking the " risk based approach" Perform all job duties and responsibilities… more
