Sr. Manufacturing Process Engineer
Listed on 2026-02-19
-
Engineering
Process Engineer, Quality Engineering, Manufacturing Engineer, Biomedical Engineer
Sr. Manufacturing Process Engineer
Company: Beckman Coulter Diagnostics
Location: Hebron, KY
Employment Type: Full Time
Date Posted: 02/05/2026
Job Categories: Engineering, Manufacturing and Production
Job DescriptionBring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences,diagnostics and biotechnology?
AtBeckman Coulter Diagnostics, one of Danahers 15+ operating companies, our work saves livesandwereall united by a shared commitment to innovate for tangible impact.
Youllthrive in a culture of belonging where you and your unique viewpoint matter. Andby harnessing
Danahers 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 laboratorys 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 makingwe 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 semi automated 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 willbeanon-siterole supporting our Reagent Operations facility locatedin
Hebron, KY.
- 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).
- Education & Experience: Bachelors in Engineering (Mechanical, Electrical, Industrial, Biomechanical) with 5+ years, or Masters with 3+ years of experience.
- Industry Expertise: Minimum 3+ years in process engineering, preferred within regulated manufacturing (IVD, medical device, pharma, or biotech), with focus on reagent manufacturing.
- Technical
Skil…
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