"About Industry X A new area within Accenture Digital is Industry X, an advanced, digitally enabled, innovative, planning and investment approach for manufacturing and asset-intensive industries. In your role within our Industry X team, you’ll help clients take advantage of significant market opportunities as digital technology moves into the core of industry in product development and manufacturing environments. You’ll help them transform their product, manufacturing and product-related services value chains in Products, Communications, Media, High Tech, Chemicals, Mining, Oil & Gas and Utilities. As part of Accenture Digital, you’ll benefit from tailored career management and specialist skills that will fuel your ambitions in the Industry X space. We are looking for CSV Engineer to extend our Industry X embedded software engineers team, who already enjoy working with high-end technologies on various exciting multinational projects! What’s in it for you? · You can either work remotely, hybrid or on-site, · Flexible hours · Life & Health insurance with wide coverage including spouse and children · Meal allowance · Employee Referral Bonus Program · Performance rewarding bonus & promotion · Birthday day off · No dress code needed · Personal ongoing learning budget · Accenture Recognition points that can be turned into gift cards, holiday offers, etc · Working on international projects with a globally diverse team · A fast-paced technology environment · An Employee Assistance & Wellness Program including access to telephone counseling, webinars, training, interactive tools, online and digital content · Personalized career development plan with People Leads · Buddy system to support your integration
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 5 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
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