Computer Validation Expert (Barleben, Hybrid, ITIL, GAMP5, 21CFR11, ENG/GER)

D-ploy is an IT and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA.We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT community, we optimize our customer‘s IT productivity and contribute to the organization’s success and value.We are interested in talking to engaging, flexible, and solution-oriented individuals who are looking to become a part of a dynamically growing and international organization. We are focused on creating value where IT counts, join us!Tasks and Responsibilities: Define validation approach, create and own the relevant documentation and activity in alignment with CSV framework and other applicable regulations and applications Manage or support CSV projects with focus on applications together with internal employees and external consultants/vendors as needed Manage or support qualification of software components supporting regulated systems Provide consultancy regarding CSV compliance within the Group IT and other stakeholders as needed Support of local Application Management Team regarding of validation and review tasks Support and participation in Group IT Quality related Audits Requirements Experience in the field of Computer Systems Validation (CSV) Good knowledge in applicable regulations and standards: GAMP5, ITIL, 21CFR11 Project Experience Very good written and spoken English and German skills Good communication, intercultural and networking skills with the ability to work independently in a well-structures and systematic manner Proactive and structured way of working, solution orientation as well as a distinctive ability to work in a team Flexibility and ability to adapt in a fast-paced environment Benefits Broad range of activities, tasks, and projects Flexible working conditions Minimum 5 weeks of vacation Paid sick days Meal vouchers Vouchers (B-day voucher, wedding, and new born surprise) Contributions to wellness programs (multisport card) Fishing for Friends program – our referral program Refreshments in the D-ploy office Further development and professional advancement Friendly and international working environment Company-sponsored events Competitive salary and various benefits