Product Software Engineer – V&V Engineer

About the job you’re consideringGeneral Project Support·Attend Weekly Project Meetings·Attend Daily Construction Meetings·Attend Monthly EH&S Safety Meeting·Generate Work Orders·Generate Memos / Interoffice Correspondence·Generate Meeting MinutesGeneration and Modification of project lifecycle documentation for LA Plant Site.o User Requirement Specificationso Functional Specificationso Design Specificationso SOPso Management of Change (MOC)o FMEAo HAZOPso Risk Assessmentso Gap Assessmentso Project Closeout Documentationo Turnover Package Generationo Project Change RequestsManagement of Project Change Control Records (PRs)o Generate/Initiateo Manageo CloseSupport Takeda and A/E Firm in Project Designo Conceptual Designo Basic Designo Detailed Designo Design ReviewConstruction Activitieso Generate and Manage Safety Management Plans and Documentationo Disruptive Construction Activity Requestso Job Hazard Analysiso Lockout Tag Out Plano Hot Work Permittingo Permit to Worko Detour Planso Construction Signageo Plant-wide Communicationso Generate and Manage Quality Management Plans and Documentationo Construction Control Plano Assist in site supervision of construction personnel.Manage Installation and Operational Commissioningo Author and Approveo Executiono Function Testingo BOM Updateso PM Generationo Asset Lifecycleo Drawing Updateso Support site acceptance testing to review system documents and functions during SAT.o Summary ReportManage Installation, Operational, and Performance Qualificationo Author and approve.o Develop and execute qualification protocols.o Assist with any deviation resolution and handling.o ExecutionSummary Report Training and Documentationo Train personnel on the operation of the Fractionation process, and related procedureso Create comprehensive documentation of all validation activities.Risk Assessment and Mitigationo Identify and assess potential risks to product quality and patient safety.o Develop mitigation strategies and contingency plans.Change Controlo Manage change control for any modifications or updates to the equipment or processes.Quality Auditso Conduct internal and external audits to ensure compliance with quality standards and regulations.Start up support.o Start up support for process equipment and facility as required.Your roleVALIDATION SUPPORTInstallation Qualificationo Equipment installation verification and confirmation that equipment is installed inAccordance with manufacturer’s specifications.o Document equipment installation and location.Operational Qualification· Equipment functional verifications under operational conditions.· Conduct testing of equipment functionality and performance.· Documenting of all test results and deviationsPerformance Qualification· Confirmation of the fractionation performance· Validate the manufacturing process and critical process parameters.· Generate and review batch records and documentation.Process Validation· Conduct process validation studies to ensure consistent product quality.· Perform risk assessments and implement process controls.Your skills and experienceInstallation Qualification, Operational Qualification, Performance Qualification, Process Validation, Cleaning Validation, Software Validation, Facility Qualification, FMEALife at CapgeminiCapgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer:

• Flexible work
• Healthcare including dental, vision, mental health, and well-being programs
• Financial well-being programs such as 401(k) and Employee Share Ownership Plan
• Paid time off and paid holidays
• Paid parental leave
• Family building benefits like adoption assistance, surrogacy, and cryopreservation
• Social well-being benefits like subsidized back-up child/elder care and tutoring
• Mentoring, coaching and learning programs
• Employee Resource Groups
• Disaster Relief

About Capgemini EngineeringWorld leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has 65,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities &Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.Capgemini Engineering is an integral part of the Capgemini Group, a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of €22.1 billion.Get the future you want |DisclaimerCapgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship.Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.Click the following link for more information on your rights as an ApplicantApplicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.