Continuous Improvement Engineer (CI) – AI and Automation

Continuous Improvement Engineer - AI and Automation

Position Summary

• Monday-Friday 8 AM-5 PM.

• This position is 100% on-site in Winchester Kentucky.

Catalents Winchester location is the flagship US manufacturing location for large scale oral dose forms with integrated analytical and development services. With 28 years of expertise in product development technology transfers and commercial manufacturing and roots in industry-leading Glatt technology.

The CI Engineer AI and Automation is responsible for driving operational excellence within our manufacturing operations. This role will focus on leveraging artificial intelligence machine learning and automation technologies to optimize production processes enhance quality and ensure compliance with regulatory standards.

The Role

• Identify and lead process improvement initiatives across manufacturing operations using Lean Six Sigma and AI-driven approaches.

• Design and implement intelligent automation solutions to reduce manual effort improve throughput and enhance product quality.

• Collaborate with cross-functional teams including Quality Engineering IT and Regulatory Compliance to ensure solutions are compliant with cGMP and FDA regulations.

• Develop and deploy predictive analytics models to monitor equipment performance detect anomalies and prevent downtime.

• Integrate AI and automation tools with existing MES ERP and LIMS systems to streamline data flow and decision-making.

• Conduct root cause analysis and implement corrective/preventive actions (CAPA) using data-driven insights.

• Support digital transformation initiatives and contribute to the development of smart manufacturing capabilities.

• Train and mentor operations and other cross-functional teams on new technologies and continuous improvement practices.

• Other duties as assigned.

The Candidate

• Bachelors in Engineering Computer Science Pharmaceutical Sciences or related field (Masters preferred).

• 3 years of experience in pharmaceutical manufacturing process improvement or automation engineering.

• Strong knowledge of GMP FDA and other regulatory requirements in pharmaceutical production.

• Proficiency in AI/ML tools (e.g. Python TensorFlow Azure ML) and automation platforms (e.g. UiPath Rockwell Automation Siemens).

• Experience with data analytics process modeling and digital manufacturing systems.

• Lean Six Sigma certification (Green Belt or higher) strongly preferred.

• Ability to sit or stand for extended periods while working at a computer or on the production floor.Occasional lifting of equipment or materials up to 25 lbs may be required.Manual dexterity to operate tools devices and computer systems.Ability to move between office lab and production environments as needed.Individual may be required to sit stand walk for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor.

Why You Should Join Catalent

• Several Employee Resource Groups focusing on D&I

• Tuition Reimbursement Let us help you finish your degree or earn a new one!

• Generous 401K match

• 152 hours accrued PTO 8 paid holidays

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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