**About the job you’re considering** + Develop and document user and functional requirements, test cases, scripts, and validation protocols in alignment with company, GxP, and regulatory policies. + Collaborate with cross-functional teams to gather and analyse requirements and ensure that validated systems address user needs and acceptance criteria. + Execute validation testing, document findings and discrepancies, and work with PAS-X MES modeler and engineer teams to resolve issues identified during testing. **Your role** + Associates degree (or local equivalent) in journalism, technical communication, English, bio-medical engineering, science writing, or other related discipline or at least 3 to 4 years of experience as a technical writer + Minimum of 3-4 years of technical writing experience + Familiarity with conventions in form, structure, and notation of technical writing + Exceptional written, organizational, inter-personal, project management, and communication skills + Proficiency in, XML authoring tools, content management systems, Excel, Word, Outlook and PowerPoint + Experience in DITA Good to Have + Highly motivated with the ability to work well both independently and in a team environment. **Your skills and experience** + Bachelor’s degree in bio-medical engineering, mechanical, journalism, technical communication, English, science writing, or other related discipline. + Writing experience in the medical device industry or any relevant industry + Experience in writing user and service manuals / documents and using content management systems and xml authoring tools. + Experience with SOP Creation/updates of functions specifications designed documentation etc. + Must have Test Script and technical documentation associated with GMP and SDLC in a controlled environment. + Understanding of documentation aspect of software development cycle - waterfall and Agile Methodologies. **Life at Capgemini** Capgemini 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 Engineering** World 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 | www.capgemini.com **Disclaimer** Capgemini 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 Applicant http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law Applicants 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. **Job:** _Programmer/Analyst_ **Organization:** _ERD PPL US_ **Title:** _E/E & Semiconductor Engineer - Technical writer_ **Location:** _NJ-Raritan_ **Requisition ID:** _080524_