QUALIFICATION/VALIDATION ENGINEER*IN

Job description

AKKA is the world leader in Engineering and Technological Consulting Services. By accelerating
innovation among its customers, AKKA supports the leading players in the automotive, aerospace, telco
& media, industrial, energy, railway, and life science sectors throughout the life cycle of their products,
also made with cutting-edge digital technologies (ADAS, IoT, Big Data, robotics, embedded systems,
machine learning, etc.). We are looking for:

QUALIFICATION/VALIDATION ENGINEER*IN

Tasks

·  Independent planning and execution of work packages and subprojects on
qualification/validation (project management and coordination) with focus on computer system validation
·  Execution of risk analyses according to specifications and standards Independent preparation, review and update of qualification and validation documents for routine and complex tasks
·  Consulting for various local and global (=international) projects on the topic of qualification and validation
·  Interface management to IT department, global quality department as well as local production sites
·  Support in local and global/cross-site projects including cost and schedule planning

Requirements

·  Successfully completed scientific, engineering/computer science studies or comparable education including further education (FH)
·  Several years of professional experience (> 5 years) especially in the field of qualification and validation with advanced knowledge in computer system validation (CSV); experience in the pharmaceutical industry desirable
·  Very good knowledge of the relevant standards and laws (e.g. GMP, data integrity, GAMP, 21 CFR Part 11, EU-GMP Annex 11, etc.) and the requirements for qualification and validation of computer systems
·  You have an independent and structured way of working and bring along a high degree of willingness to learn, enthusiasm and motivationYou have a good understanding of technical basics and a distinct affinity for IT
·  Intercultural openness and communication skills are a matter of course for you and you see working in a team as an enrichment

Profile

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