Shrewsbury, MA, 01546, USA
26 days ago
Lead NPI Manufacturing Engineer
Be part of something altogether life-changing! Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term. Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. As a Lead NPI Manufacturing Enginee r at Cytiva, you will oversee the successful transfer of new products within the Upstream & Fluid Management business unit, including hardware and single-use consumables. Your responsibilities will include process development, statistical analysis, and the validation of processes and equipment. You will also engage in strategic activities focused on continuous improvement. This position is part of the Global Supply Chain/New Products Introductions team, located in Shrewsbury and Westborough, MA, and will be on-site. At Cytiva, our vision is to advance future therapeutics from discovery to delivery. What You Will Do: + Process Alignment: Develop and validate new manufacturing processes to introduce new products to the business. Demonstrate a solid understanding of existing processes to support improvements to the manufacturing process with a focus on upstream bioprocessing hardware and consumables products. + Technical Expertise: Serve as the primary point of technical escalation, proficient in troubleshooting, developing manufacturing equipment, tooling/fixtures, and resolving operational problems. + Productivity Improvements: Monitor and enhance productivity using DBS fundamental tools, ensuring timely and cost-effective fulfillment to meet customer commitments while focusing on manufacturability and safety considerations. + Product Quality: Contribute to continuous improvements in product quality by identifying current and future manufacturing issues. Able to perform validation activities by executing IQ, OQ, PQ, and PV activities. Proficient in writing validation protocols and reports. + Quality and Regulatory Compliance: Support the alignment of manufacturing processes with company objectives, industry best practices, and regulatory requirements, ensuring adherence to external and internal quality standards and protocols. Who you are: + Bachelor’s degree in Mechanical, Electrical, Manufacturing, or Computer Systems Engineering (or related field) with 4+ years of experience or an Associate’s degree with 5+ years of relevant experience. + Proven problem-solving skills, including troubleshooting, analysis, and planning abilities. + Working knowledge of lean manufacturing principles and quality improvement techniques. + Experience in engineering or production/troubleshooting of bioprocessing equipment. Travel, Motor Vehicle Record & Physical/Environment Requirements: + Ability to travel – 10% travel, overnight, within territory or locations. + Must have a valid driver’s license with an acceptable driving record. + Ability to lift, move, or carry equipment up to 35lb. It would be a plus if you also possess previous experience in: + Experience with Computer-Aided Design (CAD), Embedded Systems, Coding/Macros, and/or Mechanical Design is preferred. + Experience working in the Bioscience, Medical Device, or Pharma industries is preferred. + Experience with JMP and Minitab statistical tools. #LI-NS3 Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
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