Lead Process Engineer

Danaher Marlborough , MA 01752

Posted 2 weeks ago

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.What you'll doThe R&D Process Development Engineer will be responsible for leading process development, technology transfer, and supporting production scale-up for existing products and new product introductions (NPI) for our R&D team at GE Life Sciences in Marlborough and Westborough, MA. Current processes include our hollow-fiber filter manufacturing (polymer extrusion and membrane fabrication), and our assembly lines for single-use fluid pathway consumable products.

Our products are used with bioreactors and related bioprocess manufacturing equipment in the pharmaceutical industry and are essential to produce lifesaving medicines and treatments. Work hands-on to install, modify, and de-bug new and existing manufacturing equipment, applying analytical knowledge and mechanical aptitude. Characterize the impact of equipment process variables on design outputs.

Lead the selection, capital acquisition, and acceptance testing of equipment based on analysis of specifications, risks, reliability and quality/regulatory requirements. Conduct and support process qualifications. Generate, review and update the technical content of drawings, engineering specifications, equipment specifications, protocols, reports, and other documents associated with the engineering process, and lead/participate in formal engineering design reviews.

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. Release products through the ECR/ECO process.

Aid in design of large and small equipment to meet their intended use. Ensure performance of engineering analyses (e.g., free-body diagrams, stress analyses) to aid in making design decisions. Participate in cross-functional teams, working primarily in production alongside Manufacturing engineers at the Westborough site, in a highly matrixed team environment to advance programs.

Ensure adherence to GMP and EHS safety procedures. Who you are Bachelor's degree in Engineering with 5+ years of relevant process/operations experience in mechanical engineering, Biotechnology or a related medical device/life science field. Strong mechanical aptitude, previous experience designing and executing equipment qualifications (IQ/OQ/PQ) and DOEs, knowledge of automation and PLCs, thorough understanding 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. Desired Characteristics Experience in Medical Device (ISO13485), Pharmaceutical GMP environments. Previous experience with various forms of polymer welding; traditional heat sealing (continuous & impulse) friction welding, ultrasonic and inductive would be a plus.

Experience with equipment used in the manufacture of hollow fiber, fiber spinning, melt spinning, and wet spinning. Design for Six Sigma or Green Belt/Black Belt Certification. 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.Want to know more? Take a look at our Instagram, Twitter and LinkedIn pages!Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health.

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.As part of the Danaher family of companies, our work at Cytiva is supported by a global science and technology innovator. In addition to Danaher's unrivaled leadership training and professional development programs, our relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life's Potential.

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.



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VIEW JOBS 10/13/2020 12:00:00 AM 2021-01-11T00:00 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. What you'll do The Principal Process Engineer will be responsible for leading process development, technology transfer, and supporting production scale-up for existing products and new product introductions (NPI) for our R&D team in Marlborough and Westborough, MA. Current processes include our hollow-fiber filter manufacturing (polymer extrusion and membrane fabrication), and our assembly equipment for single-use fluid pathway consumable products. * Research technologies and equipment to identify alternative and advanced methods to develop new processes for product manufacture and assembly. * Work hands-on to install, modify, and de-bug new and existing manufacturing equipment, applying analytical knowledge and mechanical aptitude. * Characterize the impact of equipment process variables on design outputs. * Lead the selection, capital acquisition, and acceptance testing of equipment based on analysis of specifications, risks, reliability and quality/regulatory requirements. * Conduct and support process qualifications. * Manage process development project schedules and related activities. * Generate, review and update the technical content of drawings, engineering specifications, equipment specifications, protocols, reports, and other documents associated with the engineering process, and lead/participate in formal engineering design reviews. * 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. * Release products through the ECR/ECO process. * Aid in design of large and small equipment to meet their intended use. Ensure performance of engineering analyses (e.g., free-body diagrams, stress analyses) to aid in making design decisions. * Participate in cross-functional teams, working primarily in production alongside Manufacturing engineers at the Westborough site, in a highly matrixed team environment to advance programs. * Guide and mentor R&D engineers on process development. * Ensure adherence to GMP and EHS safety procedures. Who you are * Bachelor's degree in Engineering with 15+ years of relevant process/operations experience in mechanical engineering, biotechnology or a related medical device/life science field. * Strong mechanical aptitude, previous experience designing and executing equipment qualifications (IQ/OQ/PQ) and DOEs, knowledge of automation and PLCs, thorough understanding 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 with working within an ISO 9001/13485 and/or cGMP environment. * Demonstrated ability to solve problems, develop plans and advance to completion on-time and in-full. * Diverse technical understanding and ability to apply skills/knowledge to new technology. * Demonstrated collaboration, negotiation & conflict resolution skills. * Ability to multi-task & handle tasks with competing priorities effectively. * Previous experience with various forms of polymer welding; traditional heat sealing (continuous & impulse) friction welding, ultrasonic and inductive would be a plus. * Experience with equipment used in the manufacture of hollow fiber, fiber spinning, melt spinning, and wet spinning desirable. * Design for Six Sigma or Green Belt/Black Belt Certification desirable. 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. Want to know more? Take a look at our Instagram, Twitter and LinkedIn pages! Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. 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. As part of the Danaher family of companies, our work at Cytiva is supported by a global science and technology innovator. In addition to Danaher's unrivaled leadership training and professional development programs, our relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life's Potential. 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. 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. Danaher Marlborough MA

Lead Process Engineer

Danaher