CSV Engineer

As Manufacturing & Operations, part of Accenture, we are working in the domain of Manufacturing Execution Systems (MES), which means that the solutions we are working on are directly impacting how factories around the world are managing their manufacturing processes. We are looking for an ambitious CSV Engineers ready to take on new challenges. As industries head towards Manufacturing and Factory Digitalization, MES stands in the center of manufacturing excellence. 📢What’s in it for you? ✨ Work-Life Balance: Remote working model / Flexible hours / Birthday off / No dress code / Happy Hours 🩺 Health & Wellness: Life & Health Insurance / An Employee Assistance & Wellness Program 💰 Financial Benefits: Meal allowance / Employee Referral Bonus Program / Performance bonus & promotion / Accenture Recognition Points 💪 Professional Development: Learning budget / Personal career development with People Leads / Buddy Program 🌎 Work Environment : Working on international projects with a globally diverse team / A fast-paced technology environment Key Responsibilities: Coordinating validation activities for the respective system, including but not limited to Manufacturing & Operations systems, Generating, reviewing, signing off, coordinating & executing various program & GMP related documents and protocols, including but not limited to the following: Validation Master Plan, Validation Plan, URS, FS/DS, Risk Assessment, Test Plan, Test Specifications (IQ/OQ/PQ), relevant Summary Reports and change control Establishing internal and external training activities for the project, Supporting operational life cycle activities wherever relevant, including the Impact assessment for the Change Management and Incident Management, Periodic Review, etc. and coordinating the maintenance of deliverables as required. Required Qualifications : Bachelor’s Degree in Engineering, Master’s Degree is a plus Preferably, minimum of 3 years of CSV experience in a quality and/or GMP/FDA regulated environment Being familiar with industry regulations, including but not limited to FDA, EU, etc. Having know-how on GAMP 5 • 2nd Edition, Data Integrity and ERES requirements Exposure to Manufacturing & Operations systems is highly desirable Previous experience working as part of a large, multi-disciplinary team Excellent technical writing skills Strong analytical, problem solving, planning, detail-oriented and interpersonal skills required Strong written and oral communication skills needed Fluency in English is a must Ready to make an impact? If you are excited about working with cutting-edge technology and participating in thrilling international projects, we want to hear from you! Join Accenture and achieve your goals. #GreatPlaceToWork Apply Now!