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Danaher Corporation Senior Process Engineer-Filtration 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.

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.

What you’ll do

  • Establish expertise with polymer extrusion and membrane fabrication.

  • Apply chemical engineering principles with process engineering experience to design and conduct reproducibility and quality testing of products.

  • Conduct and support product performance experiments as part of production and process evaluations.

  • Characterize the impact of equipment process variables on design outputs.

  • Participate in the capital acquisition process from requirements creation through commissioning according to existing procedures and work instructions.

  • Conduct and support process qualification testing of equipment.

  • Generate, review, and update the detailed design documentation to ensure a complete equipment history for new capital systems including piping drawings, hardware specifications, automation specifications, system requirements, protocols, reports, and technical design reviews.

  • Identify, analyze, own, and drive technical solutions to resolution.

  • Participate in the preparation and review of performance and functional requirements, risk management, and other project documents.

  • Complete PFMEA, Control Plan, and support SOP generation associated with product transfers and launches.

  • Generate, execute and analyze DOE, characterization and measurement system analysis (MSA) studies for new products and new processes.

  • Aid in design of large and small equipment to meet their intended use.

  • Work collaboratively in inter-department and cross-functional teams inclusive of Manufacturing, Operations Engineering, Quality Assurance, Quality Control, and Facilities in complex projects.

  • engineers at the Westborough site, in a highly matrixed team environment to advance programs.

  • Ensure adherence to GDP, GMP and EHS safety procedures.

Who you are

  • Bachelor’s degree in Chemical Engineering with 5+ years of relevant manufacturing engineering or process engineering in biopharmaceutical or medical device manufacturing.

  • Strong mechanical aptitude, previous experience designing and executing equipment commissioning (FAT/SAT) and qualifications (IQ/OQ/PQ).

  • Strong knowledge of application of DOEs for the evaluation of process parameters.

  • Thorough understanding of automated control at the system level for batch or continuous management of electrical/mechanical, fluid delivery/pumps, and pneumatic systems.

  • Excellent verbal and written communication skills to technically and professionally describe test scenarios, deviations, non-compliances and risks.

  • Experience in Medical Device (ISO13485) or Pharmaceutical GMP environments.

  • Previous experience with tangential flow filtration manufacturing would be a plus.

  • Experience with equipment used in the manufacture of hollow fiber, fiber spinning, melt spinning, and wet spinning.

  • Experience with equipment used in the manufacture of hollow fiber, fiber spinning, melt spinning, and wet spinning.

  • Experience with technical or project leadership.

  • Ability to work independently, within teams and cross-functionally depending on the requirements of the project.

  • Ability to think out-of-box to discover new and novel ways to promote test methods and analyse results.

  • The individual enjoys rolling up their sleeves to get the job done either independently or in a team environment.

  • Skilled with statistical analysis and its application to process and equipment design and equipment verification and validation.

When you join us, you’ll also be joining Danaher’s global organization, where 68,000 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.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

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

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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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