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! 

About Accenture

Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world’s leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities.

Visit us at www.accenture.com 

Equal Employment Opportunity Statement

We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, sexual orientation, gender identity or expression, marital status, citizenship status or any other basis as protected by applicable law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.