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.
We are seeking a Senior Systems Engineer with a software and hardware background to join our product development team for cell therapy manufacturing equipment. As a Senior Systems Design Lead, you will manage various engineering aspects of development, tech transfer, and launch of a novel, industry-leading manufacturing system for personalized/autologous cell therapies. In this role, you will engage in all facets of product development including concepting, documentation, design, prototyping and transfer to manufacturing to meet the needs of Millipore Sigma’s quality systems and a complex regulatory environment. The candidate must have the drive to solve complex technical problems, work in a fast-paced environment, and across multiple internal and external stakeholders and subject matter experts.
- Lead activities in the arena of manufacturing platform development for autologous cell therapy.
- Collaborate with a diverse group of engineers, biologists, software designers, end-users and external suppliers.
- Participate in the translation of user and functional requirements to design specification, concepts and directions.
- Assist in the collection and documentation of user and functional requirements.
- Design within parameters of applicable compliance and human factors standards for ease of marketing.
- Execute project scope throughout the concepting, design and pilot phases.
- Review technical documentation produced by colleagues, including conceptual design, mechanical drawings, and technical reports.
- Adhere to high-quality industry standard development principles while delivering solutions on-time and on-budget.
- Respond to malfunctions to identify root issues and drive solutions in the product design.
- Adhere to our Quality System for activities including design control, risk management, and change control.
- Generate and review documentation required for manufacturing technical transfers.
- Support of activities pertaining to market-readiness of product, including qualification activities.
Who You Are:
- Degree in Chemical, Electrical, Computer Science, Bioprocessing or related engineering field: Bachelors with 10+ years’ experience, Masters with 8+ years’ experience, PhD with 5+ years’ experience in designing integrated systems for medical or pharmaceutical industry
- Sound knowledge of design, development and manufacturing transfer
- Industry experience in automation for process equipment with a proven track record for designing, implementing and supporting automation solutions for complex multidisciplinary problems
- Familiarity with FDA and EMA requirements for manufacturing equipment and software, including 21CFR part 11 and GAMP5 guidelines, and UL and EMC certifications.
- Advanced understanding of mechanical, electrical and software systems, focus on mechanical
- Strong innovation and creativity in design solutions
- Strong leadership and communication skills with ability to make decisions
- Independent management of time across multiple tasks/projects
- Quality and accuracy of documentation
- Advanced understanding of cell culture principles and bioreactor-based platforms
- Experience working with CDMOs for research and manufacturing
- CAD Skills (Solid Edge preferred)
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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