Senior Expert* Qualification & Validation Pharma

Senior Expert Qualification & Validation Pharma Full-time Wasserburg am Inn 38 week hours 30 holiday days MEGGLE – The brand with the Kleeblatt Our diverse range of butter specialities delights “Gourmeggles” worldwide. With our milk dry products we are partners of the food processing industry, with our lactose even leading in the pharmaceutical industry. Founded over 135 years ago as a small cheese mill, MEGGLE is one of the most renowned producers of dairy products in Europe. At the time as today, MEGGLE stands for the highest quality. Over generations and cultures, more than 1,000 employees at the Wasserburg site are constantly developing and are celebrating success together. We are the team MEGGLE! MEGGLE welcomes all people.

In this position you are responsible for qualification of production facilities, media systems and rooms for the product range of pharmaceutical production.

Responsible planning and control of qualification and validation projects in compliance with GMP guidelines and documentation, in close cooperation with other departments In this role, plan, structure and moderate project meetings and workshops and act as an expert for the documentation creation and execution of URS, risk analyses, DQ, IQ, OQ, PQ for installations and spaces according to GMP requirements Evaluation, development of solutions and coordination of the processing of deviations from qualification and validation activities as well as evaluation and follow-up of pendencies during qualification Professional integration of new employees in the field of qualification / validation and development of training content for project members Creation, review and update of SOPs, validation plans and reports as well as risk analyses, in particular the specific validations of CIP purifications, heaters (CCPs) and foreign body inspection systems (X-ray or metal detectors), and verification of processes (verification) Presentation of qualification and validation documents in customer and certification audits

Successfully completed studies in food technology, process engineering, chemical engineering, pharmaceutical engineering, mechanical engineering or a comparable field Multiannual professional experience in the pharmaceutical environment Knowledge of common GMP regulations Expertise in the qualification/requalification of systems/devices, elaboration of URS as well as creation/moderation of risk analyses (e.g. FMEA) Technical know-how of machines, plants and processes as well as technical standards and guidelines (e.g. EHEDG, VDMA) in the field of application Systematic, careful and targeted working methods as well as pronounced analytical skills High level of commitment, initiative and organisational talent Representative communication and problem-solving competence Secure handling of MS-Office and SAP Very good knowledge of German and English in word and writing

We offer a safe workplace with versatile tasks. We accompany you on your career path and offer you individual training opportunities.

Thanks to our cooperation with famPLUS, you will receive support in all situations of life – whether in nursing advice or child care. In addition, you can benefit from numerous financial advantages: For a healthy and active lifestyle we grant your EGYM Wellpass and your JobBike leasing.

Our corporate culture is characterised by cohesion - so we regularly organize employee events, promotions and team building activities to strengthen cooperation. And the best thing: Our tasty products can be purchased at the discounted sales! JOBV1_EN