- Novo Nordisk (Plainsboro, NJ)
- …file library and documentation: manage all files generated during the call-plan process , and ensure files are accurate, reconciled, and distributed to downstream ... and reliable for field users + Oversee the field call-plan refinement process : create project timelines, communicate milestones to stakeholders, manage inquiries and… more
- Integra LifeSciences (Plainsboro, NJ)
- …new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & ... agencies. **Primary responsibilities are:** **(Validations, Risk Management and Statistical Process Controls)** To perform this job successfully, an individual must… more
- Bristol Myers Squibb (Summit, NJ)
- …the site CMMS system. + Support execution of equipment performance verification and process improvement studies. + Adhere to all ECQ team policies and procedures to ... cGMP, GXP, GAMP, SDLC regulations (including 21CFR part 11), computer systems validation requirements, and good documentation practices. + Advanced knowledge of … more
- Merck (Rahway, NJ)
- …analytical datasets, tables, figures, and submission deliverables and perform validation activities following departmental SOPs. The senior statistical programmer ... of observational research or statistical terminology and concepts + Experience ensuring process compliance and deliverable quality + Strategic thinking - ability to… more
- Sumitomo Pharma (Trenton, NJ)
- …& Project Management, including the Software Development Lifecycle and Computer Systems Validation process + Excellent communication skills The base salary range ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in...+ Continuously assess current systems environment and identify changes ( process and/or system) that enhance effectiveness + Assist in… more
- Actalent (Parsippany, NJ)
- …We are looking for an Aseptic Technician to assist with the validation of new areas, including manufacturing equipment and processes. You will collaborate ... issues and resolve deviations. Your role will involve participating in aseptic process simulations, media fills, and equipment qualifications, as well as conducting… more
- Bristol Myers Squibb (Princeton, NJ)
- …automation, system upgrades, and stakeholder feedback.** + **Manage platform security, validation , and compliance in coordination with IT and cybersecurity teams.** ... HPC, Kubernetes, and parallel/distributed computing.** + **Familiarity with software validation , compliance, and best practices in regulated environments.** +… more
- Sumitomo Pharma (Trenton, NJ)
- Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused on addressing patient ... or follow us on LinkedIn. The IRT Manager serves as the business/ process owner for Interactive Response Technology systems across SMPA oncology studies. This… more
- AbbVie (Branchburg, NJ)
- …(OT) Systems as per AbbVie change management procedures for the manufacturing process , utilities and Facilities Control Systems. This role is responsible for leading ... the development and execution of OT Systems lifecycle deliverables, including validation activities and associated documentation like System Functional and Design… more
- Astrix Technology (Piscataway, NJ)
- …High: 40.00 **Facilities & Equipment Maintenance Technician - Biotech / Pharmaceutical Manufacturing** Join our client's team to maintain critical facility systems ... and process equipment in a GMP-regulated biologics environment. You'll work...or equipment maintenance within a **GMP-regulated biotech, biopharmaceutical, or pharmaceutical environment.** + Hands-on experience with HVAC systems, chillers,… more