Danaher Corporation Lead Process Development Engineer in Westborough, 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 a Lead Process Development Engineer to lead our efforts to qualify a wide range of equipment by following the highest quality standards to fulfill Customer Expectations. You will work with a cross-functional team from Global Supply Chain, Engineering, and Quality Assurance responsible to establish a process for manufacturing products produced at the Westborough Site You will be accountable for achieving the Process Yield Goals and DPU targets. Does this sound like your passion? Then we would love to hear from you.
What you’ll do
Establishment Equipment requirements by working closely with suppliers and the cross-functional GSC Team in the form of Equipment Requirement Specification. Align the Equipment Specification to reliability and quality requirements
Lead the team with hands-on work related to Process Development to define parameters for the equipment to meet the quality goals.
Apply Analytical and quantitative problem-solving using methods including but not limited to Root Cause Analysis and Design of Experiments
Ensure Design Output meets the goals set by User Requirement Specifications and System Requirement Specifications
Define Master Validation Plan for the overall Manufacturing Process as well as Qualification Strategy for individual equipment
Lead preparation of protocols for qualification documents including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Facilitate Manufacturing Design Reviews through preparation of Process Maps, pFMEA, and Risk-Mitigation Plans
Publish standard methodologies around Process Development; coach and mentor team members on Lessons Learned
Who you are
Bachelor’s Degree in Engineering, or equivalent degree with 5 or more years of working experience in the following areas: mechanical equipment/automation engineering/supply chain/ manufacturing
Experience in executing equipment qualifications (IQ/OQ/PQ) and DOEs, knowledge of automation systems including Hydraulic, Pneumatic, and Electrical Actuation Systems.
Strong verbal and written communication skills with capability to communicate sophisticated technical information in the context of Product Development and R&D.
Previous experience in heat sealing of polymer films using common industry practices
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? Experience life at Cytiva on our 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/) !
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) .