Sr. Manufacturing Process Engineer

Danaher • Hebron, KY

2d • Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. The Senior Process Engineer is a pivotal role responsible for the full lifecycle management of semiautomated and automated equipment processes, encompassing development, installation, support, and continuous improvement. This position drives critical projects focused on enhancing overall equipment operational performance, specifically targeting improvements in Preventative Maintenance effectiveness, reject reduction, maximized output, and minimized downtime. The role demands hands-on problem-solving, troubleshooting, creation of robust designs and documentation, efficient project task execution, and seamless collaboration with cross-functional teams. This position reports to the Engineering Manager, is part of the Global Engineering team, and will be an on-site role supporting our Reagent Operations facility located in Hebron, KY. In this role, you will have the opportunity to: Process Optimization & Improvement: Identify, develop, and implement process improvements using Lean, Six Sigma, and other continuous improvement methodologies. This includes optimizing yield, throughput, cost, and cycle time. Apply statistical tools (SPC, DOE) for process monitoring, data analysis, and to drive data-driven decisions for process improvements and problem-solving. Validation & Qualification: Author and execute validation protocols (IQ/OQ/PQ) for new equipment, processes, and software in a regulated environment. Documentation: Create and revise manufacturing process instructions, standard operating procedures (SOPs), batch records, validation reports, and other technical documentation to ensure compliance and consistency. Cross-functional Collaboration: Partner effectively with R&D, Quality Assurance, Manufacturing Operations, Supply Chain, and other engineering disciplines to achieve project goals and support operational excellence. Risk Management/Compliance: Identify potential process risks and develop mitigation strategies in accordance with Beckman Coulter's quality system requirements. Ensure all manufacturing processes and documentation adhere to relevant regulatory standards (e.g., GMP FDA 21 CFR Part 820, ISO 13485).

Requirements

• Bachelor’s in Engineering (Mechanical, Electrical, Industrial, Biomechanical) with 5+ years, or Master’s with 3+ years of experience.
• Minimum 3+ years in process engineering, preferred within regulated manufacturing (IVD, medical device, pharma, or biotech), with focus on reagent manufacturing.
• Proficient in process development, optimization, scale-up, and automation in manufacturing environments.
• Knowledge of tools such as SPC, DOE, and data analysis software (Minitab, JMP); experience with Lean and Six Sigma (Green/Black Belt preferred).
• Familiarity with Quality Management Systems (QMS) and applicable regulatory requirements.

Nice To Haves

• cGMP experience
• Experience with Power BI and data modeling.
• Continuous improvement/Lean concepts including: TPM, SMED changeovers, Lean Conversion, 5S, Kaizen Basics, Problem Solving, Standard Work, Transactional Process Improvement, Value Stream Mapping and Tiered Daily Management partnered with strong teamwork, innovation, and willingness to take risks and comfortable with ambiguity

Responsibilities

• Identify, develop, and implement process improvements using Lean, Six Sigma, and other continuous improvement methodologies.
• Optimize yield, throughput, cost, and cycle time.
• Apply statistical tools (SPC, DOE) for process monitoring, data analysis, and to drive data-driven decisions for process improvements and problem-solving.
• Author and execute validation protocols (IQ/OQ/PQ) for new equipment, processes, and software in a regulated environment.
• Create and revise manufacturing process instructions, standard operating procedures (SOPs), batch records, validation reports, and other technical documentation to ensure compliance and consistency.
• Partner effectively with R&D, Quality Assurance, Manufacturing Operations, Supply Chain, and other engineering disciplines to achieve project goals and support operational excellence.
• Identify potential process risks and develop mitigation strategies in accordance with Beckman Coulter's quality system requirements.
• Ensure all manufacturing processes and documentation adhere to relevant regulatory standards (e.g., GMP FDA 21 CFR Part 820, ISO 13485).

Benefits

• Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
• Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.
• Check out our benefits at Danaher Benefits Info .
• We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees