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Danaher Corporation Lead Bioprocess Engineer - System Designer in Marlborough, Massachusetts

Be part of something altogether life-changing!

Working at Cytiva in the Life Sciences industry 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. Your health and wellbeing are important to us and together we will not compromise on safety in the workplace or the environment.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

We are looking for a Lead Bioprocess Engineer - System Designer to work with our Enterprise Solutions Process and System Design (P&SD) team. Do you have a passion for Systems Engineering? Then we would love to hear from you.

What you’ll do

  • Lead System Designer (LSD) will be responsible for the FlexFactory system design which includes but not limited to the generation of relevant design documents including equipment lists, utility requirements, process definition, user requirements specification (URS), general specification (GS), equipment configurations and design approval packages for the FlexFactory components. LSD will be responsible for providing feasible, reliable, and profitable macro level design based on customer needs and regulatory requirements.Lead the system design process from requirements development and design planning to final design approval by customer. Has overall design responsibility for the FlexFactory equipment and accessory selection and specification, design document, and testing protocol review and approval.Ensure applicable customer requirements specification (URS) can be met by the FlexFactory design, and ultimately fulfilled by the end product. Initiate the FlexFactory equipment product code registration.Coordinate the detailed design and solve any design issues during the design phase and acts as a point of contact for system design related questions. Support Manufacturing Group to ensure the completeness of the TOP, equipment set-up for Factory Acceptance Test (FAT). Address customer questions/issues during FAT and manage deviation / punch list.Participate in developing and updating the FlexFactory project schedule.

  • Support customer meetings by providing system hardware understanding.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.

  • Work closely with Customer's Subject Matter Experts (SMEs) to ensure continuous exchange of critical and technical information needed to execute design activities on time.Complete all planned Quality & Compliance training within defined deadlines.Identify and report any quality or compliance concerns and take immediate corrective action as required.

  • Work closely with Process and Consumables Design Engineers to ensure that the equipment specification meets customer and process needs, and that equipment layout is optimized for the customer facility.Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones. Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives.

  • Approximately 10-30% travel depending on project specifics and geographic location.

Who you are

  • BS or MS degree in biochemical / chemical engineering or a related engineering/life Science discipline.

  • Minimum of 5 years of relevant bioprocess experience. 2 years of direct experience working in a pilot plant or GMP manufacturing facility.

  • Working knowledge of pharmaceutical/biotech processes, equipment hardware, and single use technology. 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 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.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Given the essential job duties of this position, the employee is required to be fully vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation and applicable law.

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. If you’ve ever wondered what’s within you, there’s no better time to find out.

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