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CSV Engineer

CSV Engineer

AccentureIstanbul, Hukukcular Towers, Block B
1 gün önce
İş tanımı

As Enterprise System Partners (ESP), 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 Engineer 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

Transportation : Shuttle service / Transportation support

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

Responsibilities :

  • Coordinating validation activities for the respective system, including but not limited to Manufacturing & Supply Chain systems
  • Generating, reviewing, signing off, coordinating & executing various program & GMP related documents and protocols, including a number of 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

Skills :

  • Bachelor’s Degree in in Engineering, Master’s Degree is a plus
  • Preferably, minimum of 1-2 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, Data Integrity and ERES requirements
  • Exposure to Manufacturing & Supply Chain systems is highly desirable.
  • Previous experience working as part of a large, multi-disciplinary team
  • Excellent technical writing skills
  • Strong analytical, problem solving, planning and interpersonal skills required
  • Strong written and oral communication skills needed
  • Fluency in English is a must, second language is a plus

    • About Accenture

    We work with one shared purpose : to deliver on the promise of technology and human ingenuity. Every day, more than 775,000 of us help our stakeholders continuously reinvent. Together, we drive positive change and deliver value to our clients, partners, shareholders, communities, and each other.We believe that delivering value requires innovation, and innovation thrives in an inclusive and diverse environment. We actively foster a workplace free from bias, where everyone feels a sense of belonging and is respected and empowered to do their best work.At Accenture, we see well-being holistically, supporting our people’s physical, mental, and financial health. We also provide opportunities to keep skills relevant through certifications, learning, and diverse work experiences. We’re proud to be consistently recognized as one of the World’s Best Workplaces™.Join Accenture to work at the heart of change.

    Visit us atwww.accenture.com

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