- Catalent Pharma Solutions (Chelsea, MA)
- …its kind for DPI in North America. Catalent Pharma Solutions is hiring a Computer System Validation (CSV)/ Qualification Engineer is responsible for ... managing, developing, and implementing the Computer System Validation program and equipment qualification for the site to ensure compliance with local and… more
- Carrier (Beverly, MA)
- …day. Join us and we can make a difference together. **About this role** As a Computer Systems Validation Lead, you will lead and manage the Validation ... Program for Sensitech systems and products. The Validation Lead will work with the Sales, Product, Engineering, and Professional Services teams in the… more
- J&J Family of Companies (Boston, MA)
- …Abiomed. + Develop and execute validation plans for new and existing GxP computer systems and digital solutions. + Support Validation Master Plan (VMP) ... CSV Engineer will be responsible for ensuring that all computer systems and software applications used within...SDLC and Software V&V activities such as Requirements Analysis, Validation Plan & Report, testing, qualification , and… more
- Bristol Myers Squibb (Devens, MA)
- …required. + A minimum of 7+ years relevant experience with process equipment, computer systems , manufacturing process control systems (automation) and ... and/or Leads installation, commissioning activities of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers… more
- Takeda Pharmaceuticals (Boston, MA)
- …in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems , validation , and laboratory instruments. + ... at CTMF as the Subject Matter Expert (SME) in Computer System Validation requirements. Champion QA support...including at least 5 years in GMP developing equipment qualification , and computerized systems validation … more
- Randstad US (Norwood, MA)
- …a proactive team player with exceptional communication skills and a background in systems verification & validation . The ideal candidate will have a background ... C++. This role involves leading and architecting test equipment systems , used in the development, qualification , and...cases, and test environments. + Develop and execute system validation plans to ensure compliance with specified systems… more
- RTX Corporation (Tewksbury, MA)
- …The System Engineering Directorate is the central focus for Mission Systems Integration activities within Raytheon, responsible for defining customer needs, ... and product architecture, requirements definition and decomposition, Model Based Systems Engineering (MBSE), system performance, and System Security Engineering… more
- Amazon (North Reading, MA)
- …BS or equivalent in Electrical Engineering, Aerospace Engineering, Mechanical Engineering, Computer Science, Computer Engineering, Systems Engineering, ... that are rewarding, fulfilling and fun. Amazon Robotics is seeking a Senior Systems Engineer/Architect to join a dynamic team that provides systems leadership… more
- Bristol Myers Squibb (Devens, MA)
- …. **Major Duties & Job Responsibilities:** + Gain a thorough understanding of computer systems deployed at Devens Cell Therapy Facility (CTF) at Devens ... such as BMSDocs is desirable. + Knowledge of paperless validation systems , such as ValGenesis is preferred,...quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical computerized systems field… more
- Bristol Myers Squibb (Devens, MA)
- …and defends their work before regulatory agencies. + Review and approve Computerized Systems qualification documents, as required. + Ensure that SOP's and ... System Audit Program, Change Management, Risk Management Program, as well as the Computer System Validation Program at the Devens CTF. This role will lead… more
- Medtronic (Danvers, MA)
- …manufacturing instructions. Ensure compliance with internal procedures, GMP, and regulations. ** Qualification and Validation :** Develop and execute plans for ... partner for the development and scaling of cutting-edge delivery systems . We transform concepts into unparalleled performance, enabling Medtronic...equipment qualification and process validation . Lead test method development and validation … more
- Amazon (Boston, MA)
- …engineers in the 3D art pipeline - Assisting in asset performance and validation - Solving complex technical issues during development - Deciding on what software ... Basic Qualifications - Enrolled in a degree program in Computer Science, Visual Effects, Graphic Art, Animation, or related...plus. - If you are not sure that every qualification on the list above describes you exactly, we'd… more
- Fresenius Medical Center (Lexington, MA)
- … requirements + 2+ years of professional experience working with or owning computer software validation /system coordination + Additionally, minimum of 5 years of ... IT Standard Operating Procedures (SOPs), Work Instructions (WIs), and systems . + Identify training needs for DTI IT personnel...eg Trackwise, Windchill, Agile, IQVIA etc + Knowledge of computer software validation and computer … more
- Medtronic (Danvers, MA)
- …on design with suppliers to fulfill equipment and fixturing requirements. + Qualification and Validation : Develop plans to evaluate process repeatability and ... possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking...stability through equipment qualification and process validation . + Continuous Improvement… more
- Verista (Boston, MA)
- …Qualifications Protocols, Trace Matrices and Summary Reports associated with validated computer systems + Engage in Quality process improvement initiatives, ... to completion + Review and provide feedback/approval on risk assessments, Validation Plans, Specifications, Test scripts, Installations Qualification Protocols,… more
- Medtronic (Danvers, MA)
- …manufacturing operation in order to specify equipment, fixturing, and process parameters ** Qualification and Validation :** + Develop plans to evaluate process ... possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking...repeatability and stability through equipment qualification and process validation . **Continuous Improvement and… more
- Bristol Myers Squibb (Devens, MA)
- …with departmental and product supply goals. + Reviews/approves change controls and computer system validation / qualification and provides impact assessments ... processes. The incumbent will have responsibility to implement both GMP and business systems /processes with the guidance of the Shop Floor Leadership team, with the… more
- Amazon (Boston, MA)
- …more individual items than any company in the world. We are combining computer vision, mobile robots, advanced end-of-arm tooling and high-degree of freedom movement ... to conceive, develop, prototype and deploy a wide range of robotic systems . Within Amazon Robotics, Global Operations - Artificial Intelligence (GO-AI) enables… more
- Fortive Corporation (Boxborough, MA)
- …and new product line start-up, including assembly and test equipment validation and qualification , associated with the development and commercialization ... identified during production including those related to electromechanical components and systems . + Design, develop, and qualify poka-yoke and fixturing strategies… more
- Amazon (North Reading, MA)
- …mobile robots, sophisticated control software, language perception, power management, computer vision, depth sensing, machine learning, object recognition, and ... new areas. Amazon Robotics Sensor Team is seeking a talented and motivated computer engineering or robotics student to assist with firmware development, testing, and… more