Danaher Corporation Lead Bioprocess Engineer- Consumables Design in Marlborough, Massachusetts
Lead Bioprocess Engineer - Consumables Designer
Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.
Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.
We are looking for a Lead Bioprocess Engineer - Consumables Designer to work with our Enterprise Solutions Process and System Design (P&SD) team. Do you have a passion for Single Use Technologies and Consumables Design? Then we would love to hear from you.
What you’ll do
Lead Consumables Designer will be responsible for leading consumables design/discussion for Enterprise Solutions (ES) projects including generation of relevant design documents. Lead Consumables Designer will be responsible for maintaining the Qualification Consumables BOM tool (used for quotation and for ordering consumables for qualification), Support Evaluation and Offerings (E&O) team for pre sales consumables discussion, consumables BOM, and quotation. Support generation of consumables lists for FAT/SAT/IOQ and provide consumables forecast. Work collaboratively across teams (E&O, Consumables Application, Automation, Qualification, Product Management, etc.) to ensure consistency of offerings.
Collaborate with Process Design Engineers (PDEs) and support the make-a-batch workshop. Work closely with the Consumables Application team and coordinate/support the Batch360 exercise for the ES projects. Facilitate alignment of deliverables between pre sales (proposal and technical book) and post sales activities including process and system design. Work closely with the lead System Designer (LSD) and support ES project Factory Acceptance Test (FAT) execution. Assure alignment between hardware and consumables designs.
Work closely with customer and internal Subject Matter Experts (SMEs) to ensure continuous exchange of critical and technical information needed to execute design activities efficiently and effectively. Complete all planned Quality & Compliance training within defined deadlines. Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives.
Assure compliance with the Cytiva Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to the job type/position. Identify and report any quality or compliance concerns and take immediate corrective action as required.
Approximately 10-30% travel depending on project specifics and geographic location.
Who you are
BS or MS degree in Mechanical / biochemical / chemical engineering or a related engineering/life Science discipline.
Minimum of 5 years of relevant bioprocess and single use technology experience. 2 years of direct experience working in a pilot plant or GMP manufacturing facility.
Working knowledge of pharmaceutical/biotech processes, and equipment hardware. Knowledge of biologics CMC, cGMP manufacturing requirements.
Technical understanding of automation systems used in the biopharma (Delta V, PLC, PI, etc.).
Experience in working / leading with cross functional teams. Experience with CAD, Visio, MS Project, SuperPro.
Disposable technology design and application experience. Detail oriented, excellent at critical analysis and problem solving.
Comfortable working in global business environment. Structured, Organized, Analytical, Team oriented. Fluent in English both verbally and in writing.
Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.
Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page!
Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.
Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.