Qualification engineer (m/f/d)

• flexible working hours and the option to work remotely for up to one day a week
• remuneration above the collective agreement rate and attractive additional benefits
• company pension scheme and comprehensive health benefits
• A modern canteen with a varied menu
• Good links to public transport and free parking
• A culture of informality and transparent communication

What you can always count on at persona service:

• thorough preparation for your interview with our client
• a monthly allowance of €50 towards your travel costs, depending on the role – e.g. for the Deutschlandticket and much more
• Bonuses, as well as holiday and Christmas pay, and attractive industry-specific allowances
• Free tuition for your children on the Ubimaster learning and tutoring platform
• Numerous shopping discounts with well-known brands via our corporate benefits programme
• Excellent personal support and regular feedback meetings
• A wide range of further training opportunities

You will be responsible for managing and coordinating all qualification activities for pharmaceutical process plants and utility systems in the vaccine sector

You will also be responsible for preparing robust system risk assessments as part of an interdisciplinary project team

You will also oversee the preparation and thorough review of all relevant qualification documents, from DQ to PQ

Your responsibilities will also include the integration and technical management of external partners throughout the entire qualification process

As part of your role, you will support the timely preparation and processing of change controls, CAPAs and deviations

Furthermore, you will support compliance with and monitoring of all data integrity guidelines in accordance with 21 CFR Part 11

Finally, you will be responsible for coordinating all operational qualification steps with the relevant Compliance Team Lead

REQUIREMENTS

You hold a degree in Pharmaceutical Engineering, Process Engineering or a comparable engineering discipline

You also have extensive professional experience in the qualification of equipment, media or cleanrooms in a GMP environment

You are distinguished by your confident use of standard MS Office applications and a basic knowledge of CAD

You have a business-fluent command of German and a good command of written and spoken English

Furthermore, you demonstrate a high degree of initiative, flexibility and a strong sense of teamwork

Finally, you are enthusiastic and always work reliably, in a structured manner and with a strong hands-on approach

To fulfil this position of responsibility, in addition to your technical expertise, you must hold a valid work permit and be permanently resident in Germany