- BeOne Medicines (Pennington, NJ)
- …both clinical and commercial manufacturing activities. **Essential Functions:** + Serve as MST DP Subject Matter Expert ( SME ) and process lead for ... in a dynamic environment. **Preferred Skills/Experience** + Facility Start-Up + Commissioning , Qualification & Validation + Equipment and/or Process Design… more
- TAI (Fairfax, VA)
- **About the Role:** Join TAI's expert Commissioning Services team as a Commissioning & Qualification SME and take the lead on large-scale, complex ... documents and specifications, and personally executing a broad range of commissioning and qualification services, including developing system protocols and… more
- Bristol Myers Squibb (Warren, NJ)
- …GMP, BMS standards, and health authority regulations. Serve as a subject matter expert for equipment qualification in internal and regulatory audits. ... and procedures. **Role & Responsibilities:** The Senior Specialist supports the Commissioning , Qualification , and Validation team as an individual contributor… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …validation * Sterilization validation * Materials validation * Process validation Provides technical subject matter expert ( SME ) support to change ... ongoing validation maintenance. Responsible for the design, authorship, and execution of commissioning , qualification and validation studies for the any or more… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …office. **How you will contribute:** + Be a Validation Engineering representative and technical subject matter expert ( SME ) on cross-functional and ... and accountable for performing activities such as Cycle Development (CD), Design Qualification , Commissioning and Qualification , Performance Qualification… more
- Astellas Pharma (Westborough, MA)
- …+ Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert , audit hosting / support, etc. ... in resource planning for capital projects. + Provide guidance for commissioning and qualification of facilities/utilities, equipment, automated systems, and… more
- J&J Family of Companies (Titusville, NJ)
- …data to LIMS and MES systems for rapid batch release. This role will serve as the Subject Matter Expert ( SME ) for the robotics, robotics controls, and ... processing, and PLCs. * Experience with equipment / systems commissioning / qualification /validation, Process Automation, IT manufacturing systems, * Experience… more
- J&J Family of Companies (Titusville, NJ)
- …grade C cleanroom space and will be fully GMP compliant. This role will serve as the Subject Matter Expert ( SME ) for the robotics, robotics controls, and ... processing, and PLCs * Experience with equipment / systems commissioning / qualification /validation, Process Automation, IT manufacturing systems, * Experience… more
- TAI (Fairfax, VA)
- …+ Coordinate project design with other engineering disciplines. + Direct commissioning and qualification efforts for various automated systems. **You'll ... **About the Role:** We're looking for a seasoned Automation & Controls SME to take the helm in our Control System Integration Division. This is a high-impact,… more
- Lilly (Lebanon, IN)
- …medicines, while also reducing costs and environmental impact. The Area Engineer is the site Subject Matter Expert ( SME ) for the Small Molecules Building ... functional project team in assisting in the design, construction, commissioning , qualification , start-up and operational readiness of.../ customers associated with the SMB. + Be the SME with a deep technical expertise in all systems… more
- Sanofi Group (Pearl River, NY)
- …reliability or automation projects + Role as Subject Matter Expert ( SME ) in Commissioning and Qualification + Proven success in leveraging ... support function, responsible for consistent application, governance and maintenance of commissioning and qualification (C&Q) platform procedures, application of… more
- AbbVie (North Chicago, IL)
- …processing with change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities. + Experience with the following ... of automation engineering principles in the design, specification, construction, startup, commissioning and qualification of process equipment and systems for… more
- AbbVie (Worcester, MA)
- …+ Experience in change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities. + Experience with the following ... advanced automation engineering principles in the design, specification, construction, startup, commissioning and qualification of process equipment and systems… more
- AbbVie (Worcester, MA)
- …processing with change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities. + Experience with the following ... of automation engineering principles in the design, specification, construction, startup, commissioning and qualification of process equipment and systems for… more
- Sanofi Group (Swiftwater, PA)
- …you thought was possible. Ready to get started? **Main Responsibilities:** + Working as a Subject Matter Expert ( SME ) and providing support to ... meet requirements, cost, and schedule + Develop and execute commissioning and qualification documentation as required +...a project manager and assist large capital projects in SME function + Understanding of the impact of utilities… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …and change control documentation related to validation activities. + Serve as a Validation Subject Matter Expert ( SME ) during regulatory and client ... Quality, Engineering, and other departments to plan, manage, and execute commissioning , qualification , and validation activities. The individual will be… more
- Bayer (Berkeley, CA)
- …internal and external agencies; * Resolve Quality action items, write Engineering Assessments as Subject Matter Expert ( SME ); * Perform Risk Assessments ... for large projects, (AR, >$1 million); * Perform installation and operational commissioning and qualification testing of equipment and systems. Experience with… more
- VTI Life Sciences (Raleigh, NC)
- …device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the ... Ensure our plan aligns with all necessary regulations and will support successful qualification and future site regulatory inspections + SME for presentation of… more
- Fujifilm (Holly Springs, NC)
- …lifecycle, such as Validation Master Plan (VMP), in close collaboration with the technical subject matter expert ( SME ) network and Large-Scale Business ... activities from thaw through bulk fill * Provides support and direction on commissioning and qualification by utilizing technical expertise * Oversees and… more
- TAI (Rockville, MD)
- …(SOP), work instructions, operator training guides, and preventative maintenance instructions, + SME support for commissioning and qualification of ... (GDP). + Analyzing process data and driving continuous improvement initiatives. + Providing subject matter expertise for teams and projects. + Performing process… more
