Beckman Coulter Diagnostics · 3 hours ago
Sr. Manufacturing Process Engineer
Hebron, KY
Full-time
Onsite
Senior Level
$115K/yr - $125K/yr
5+ years expBeckman Coulter Diagnostics, a leading company in clinical diagnostics, is seeking a Senior Manufacturing Process Engineer to enhance equipment operational performance in their Reagent Operations facility. The role involves managing the lifecycle of automated equipment processes and driving process improvements through collaboration and continuous improvement methodologies.
BiotechnologyHealth DiagnosticsLife ScienceManufacturing
Responsibilities
Identify, develop, and implement process improvements using Lean, Six Sigma, and other continuous improvement methodologies
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)
Qualification
Required
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
Preferred
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
Benefits
Paid time off
Medical/dental/vision insurance
401(k)
Company
Beckman Coulter Diagnostics
A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 80 years.
10001+ employees
H1B Sponsorship
Beckman Coulter Diagnostics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (27)
2023 (27)
2022 (38)
2021 (26)
2020 (32)
Funding
Current Stage
Late StageTotal Funding
unknown2011-02-07Acquired
Leadership Team
Ruth Lyons
VP North America Marketing
Recent News
2025-12-18
2025-12-17
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