A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
We are a dynamic growing, international pharmaceutical company headquartered in Reinbek near Hamburg. Within the global Merck KGaA, Darmstadt, Germany pharmaceutical, chemistry and life science group, we have with great success specialized in the development, manufacture and sale of preparations to diagnose and treat allergic diseases. We are amongst the leading pharmaceutical companies in the area of specific immunotherapy.
Your role: This position is responsible for leading the project sub team “Manufacturing and Supply” of a complex Drug-Device Combination Product. This includes project planning, budgeting, coordination of activities and reporting on project progress across all manufacturing and supply work streams as well as ensuring completion of project scope. Also, you support the Design Transfer planning, monitor and support the Design Transfer from engineering supplier to contract manufacturer up to start of serial production as well as implementation of Process Risk Management outcome into serial production. Your position involves coordinating project work with project stakeholders including Planning, Scheduling, MO and follow applicable Safety, cGMP (EU and US) Guidelines for production and coordinate and supervise external contractors and other personnel as required. You collaborate with development departments to implement changes of the device design or the primary packaging and work closely with contract manufacturing process engineers routinely to optimize processes and equipment; provide technical support during FAT and SAT of new equipment. Furthermore, you cooperate with Validation and Qualification Management during compounding, filling batch qualifications, Verifications and Validations to ensure successful execution according to cGMP requirements (EU and US).
Who you are:
- University degree in engineering, pharma or similar, (Process) Engineering Qualification desirable
- Minimum 5 years of professional experience in Pharma and Medical Devices
- Deep experience of production processes for both pharmaceutical drug and complex Medical Devices
- Profound experience in Design Transfer and Drug-Device Combination Product manufacturing
- In-depth knowledge of applicable standards in Drug-Device Combination Products development (Design Transfer) and manufacturing for both EU and US
- Experience in cGMP manufacturing environment required
- Excellent communication skills in English, German language knowledge desirable
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com