Sr. Manufacturing Process Engineer

Danaher Corporation • Hebron, KY

1d • Onsite

About The Position

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.

Requirements

• Education & Experience: Bachelor’s in Engineering (Mechanical, Electrical, Industrial, Biomechanical) with 5+ years, or Master’s 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 Skills: Proficient in process development, optimization, scale-up, and automation in manufacturing environments.
• Analytical & Quality Tools: Knowledge of tools such as SPC, DOE, and data analysis software (Minitab, JMP); experience with Lean and Six Sigma (Green/Black Belt preferred).
• Regulatory & Compliance: 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

• 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).

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.
• The annual salary range for this role is $115K - $125K. 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. 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 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level