A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 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. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Cell Therapy Processing team is developing novel technologies to enable cell and gene therapy processes. The technologies comprise of patented acousto-fluidics platforms to manipulate cell processes, such as concentration, washing, differentiation, sorting, and culturing.
We are in search of candidates with experience in validation planning of automated laboratory equipment and/or single-use disposables and materials. Your role in validation planning will include the creation of validation methods and test procedures, preparation of test setups, coordination with suppliers, collection of data, and documentation of results for reporting. Your role will involve frequent interfacing with testing laboratories, manufacturing suppliers, external development partners and internal stakeholders. Travel to internal and external sites will be required as needed to communicate and perform these duties. As part of the product development team, your role will also require close coordination with our R&D team to smoothly transition advances in technology into future products by participating in the creation of user requirement specifications and test, development and validation plans for these products as well.
Who you are:
- Bachelor's degree in Biomedical Engineering degree or related field with 3+ years of hands on experience in product development of biomedical devices or process equipment or instrumentation working within a core team structure.
- Experience with engineering change control processes and managing dynamic product designs in the transition to validated manufacturing
- Proven experience in process validation and developing, writing and executing qualification test procedures including design, implementation and documentation of test programs
- Customer-facing experience in your previous roles
- Experience interfacing with vendors and developing qualified supply chains
- Experience in the qualification and validation of engineering systems (IQ, OQ, PQ)
- Master's degree in Biomedical Engineering or related field
- Medical device or other safety critical device development including specific requirements of GMPs, GAMP5, FDA QSR and ISO 9001 standards
What we offer: With us, there are always opportunities to break new ground. 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
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