Lead Bioprocess Engineer/System Design_

Marlborough

Be part of something altogether life-changing!

Working at Cytiva 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.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The Lead Bioprocess Engineer – System Engineer for Cytiva is responsible for executing the system design deliverables for the FlexFactory team.

This position is part of the Enterprise Solutions Organization located in Marlborough, Massachusetts and will be hybrid. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will 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. This role may require approximately 10-30% travel depending on project specifics and geographic location.

+ 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.

Who you are:

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

+ 3 to 5 years of relevant bioprocess experience. Working knowledge of pharmaceutical/biotech processes, equipment hardware, and single use technology. Knowledge of biologics CMC, cGMP manufacturing requirements.

+ Experience in working / leading with cross functional teams. Experience with Visio, MS Project.

+ 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.

It would be a plus if you also possess previous experience in:

+ 2 years of direct experience working in a pilot plant or GMP manufacturing facility.

+ Technical understanding of automation systems used in the biopharma (Delta V, PLC, PI, etc.).

The salary range for this role is $80,000 – $95,000 . This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and retirement planning benefits to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

At Cytiva, we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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 (ol.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 [email protected] to request accommodation.