Danaher Jobs

Job Information

Danaher Corporation Verification Engineer - Bioprocess Equipment 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.

We are looking for a Lead Test/Verification Engineer to work in our R&D custom hardware team in support of customer projects for engineered-to-order single-use bioreactor systems. Do you have a passion for process equipment technology used for research and manufacturing of life-changing drugs? Then we would love to hear from you.

What you will do

As a Lead Test Engineer, you will support cross-functional teams by providing design verification of a modified bioreactor system’s user requirements, functional specifications and product accompanying documentation. You will select and/or develop test requirements and protocols for the modified products, and you will be trusted with independently directing and executing test activities to ensure product quality and regulatory compliance. The key responsibilities for this role include:

  • Works closely with the cross-functional core team to select and develop test requirement sets for each project that are complete, unambiguous and testable.

  • Reviews and understands modified system requirements, creates test plans, test protocols, and builds test execution strategies aligned with project’s schedule.

  • Applies design control and GDP guidelines when developing project and product documentation protocols and reports.

  • Independently selects, develops or acquires new specialized or general-purpose test equipment, samples and fixtures, as required for the project.

  • Authors acceptance test and verification protocols and reports.

  • Coordinates and manages third party testing services, if required.

  • Works closely with manufacturing engineer and ensures knowledge transfer for any new tests or equipment.

  • Coordinates with other functions the overall customized bioreactor system integration and testing with other subsystems, accessories or software.

  • Manages defect log, traceability matrix, and reviews/approves executed protocols and reports.

  • Provides support for customer witnessed Factory Acceptance Testing (FAT).

  • Prepares and/or coordinates submittals of completed verification test reports for all projects.

  • Provides mentorship, training and guidance to less experienced engineers.

  • Seeks and promotes opportunities for continuous improvement in verification testing processes and capabilities.

Who you are

  • BS in electrical, mechanical, biochemical engineering, or related field equivalent.

  • 3+ years of experience testing process hardware and software.

  • 3+ years of writing test plans and protocols.

  • Working knowledge and understanding of requirements decomposition.

  • Experience with product data management (PDM)/CAD software

  • Familiarity with typical process equipment components such as pumps, pneumatic valves, heaters, transmitters etc.

  • Basic knowledge of electro-mechanical control components, automation, PLCs and process equipment UI.

  • Experience across engineering disciplines and capability for hands-on troubleshooting of HW/SW of electro-mechanical systems.

  • Experience working in regulated environment.

  • Capacity to plan, organize, and complete tasks on time. Comfortable with working on many projects in parallel, aggressive timelines and frequent change.

  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.

  • Having customer-oriented mindset and value delivering on promised commitments.

Desired Characteristics:

  • Strong experience and knowledge with electro-mechanical and controls design typical for process equipment control panels.

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

  • Working knowledge and experience with regulated industries quality systems and relevant regulations such as cGMP, ISO 9001, ISO 13485

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) .

Careers website (https://jobs.danaher.com/global/en/cytiva) , Instagram channel (https://www.instagram.com/cytiva/) and LinkedIn page (https://www.linkedin.com/company/cytiva/) !

Cytiva is global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. 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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

DirectEmployers