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Danaher Corporation Documentation Specialist, Engineering in Marlborough, Massachusetts

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 an engineering Documentation Specialist to work with our R&D custom hardware team on projects for engineered-to-order bioreactor systems. Do you have a passion for process equipment technology used for research and manufacturing of life-changing drugs? Would you like to work on single-use bioreactor systems? Then we would love to hear from you.

What you'll doAs an engineering Documentation Specialist you will work on a cross-functional project team under the direction of the Lead Engineer and will be responsible for accurate management and safeguarding of customer-facing product accompanying documentation. Additionally, you will be trusted with creating, management and document change control of product and engineering templates and/or baselines. You will:

  • Create, revise, document and archive documents and drawing index (DDI) for each custom instrument

  • Create, revise, document control and archive Turn Over Package (TOP) content for each bioreactor system including customized packages defined by Vendor Documentation Requirements (VDR), if required

  • Assemble documents and manage customer design approval submittals

  • Ensure timely transfer to production of the TOP content and, if applicable, resolve documentation issues before the product release for shipment

  • Manage creation, release and change control for documents baselines and templates

  • Support Document Change Request (DCR) processes and Engineering Change Order (ECO) processing

  • Work within Cytiva Quality Management System and ensure that all templates follow the Cytiva hardware product documentation standards

  • Contribute to multiple projects/deliverables concurrently

  • Contribute to process improvement projects and support product documentation tasks required for custom product lifecycle engineering activities

Who you are

Minimum Qualifications:

  • Bachelor’s degree in business, engineering, or related discipline

  • Demonstrated understanding of engineering documentation such as product general specifications, drawings, component cut sheets and certificates

  • Basic understanding of Bills of Materials (BOM’s) and familiarity with engineering PDM systems

  • Experience in technical writing (SOPs, work instructions etc.)

  • Comfortable with multi-tasking, 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 holding in high regard project commitments

Desired Characteristics:

  • At least three years of relevant experience and demonstrated exposure to hardware systems documentation practices for bioprocessing process equipment

  • Familiarity with documentation and quality systems typical for pharmaceutical/biotech processes, equipment hardware, and single use technology

  • Knowledge and experience with quality systems and relevant regulations such as cGMP, ISO 9001, ISO 13485

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.

Cytiva is a 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 life sciences companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. As part of a greater Life Sciences platform, you’ll redefine what it means to innovate every day. Pioneering the future of science, research, and medicine gives you unlimited opportunities to find the next breakthrough that will best serve scientists and medical professionals in the fight to save lives.

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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