Process Engineer, Pharma Manufacturing & CI

Catalent; United States; On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Competitive PTO + holidays

Benefits from day one (medical, dental

Tuition reimbursement

Onsite engagement activities

Job summary

Catalent’s Winchester, KY site is a flagship U.S. manufacturing location for large‑scale oral solid dose forms. We seek a Process Engineer to lead projects that advance safety, efficiency, quality, and compliance on onsite capital projects and new product introductions.

The role collaborates across teams to deliver results, with a Monday–Friday 8 AM–5 PM schedule, onsite in Winchester. Ideal candidates bring engineering degree and a background in manufacturing with cGMP knowledge.

Qualifications

• Bachelor’s degree in Engineering (Mechanical or Electrical preferred).
• Proficient in English verbal and written communication.
• Proficient in Microsoft Office applications including Word, Excel, Project, and PowerPoint.
• Understanding of Automation Controls and Programmable Logic Controllers (PLC).
• Ability to work with contractors and apply current Good Manufacturing Practice (cGMP) principles to project work.
• Fundamental understanding of project management methodologies including budgeting and scheduling.
• Strong organization and communication skills with engineers, customers, and site leadership.
• Ability to generate detailed documentation such as business justifications and user requirements.

Responsibilities

• Prioritize capital projects to improve site performance and efficiency in safety, cost, and quality.
• Guide the specification and selection of process, utility, and facility equipment to support site needs.
• Manage asset reliability risks that could impact plant or business operations.
• Develop systems to identify and measure KPIs such as uptime, downtime, scrap, and yield.
• Manage continuous improvement project pipeline and prioritize based on cost, benefit, and effort.
• Organize, manage, and communicate technical progress to Business Development and Project Management.
• Work with Project Engineering to ensure reliability and maintainability of new and modified installations.
• Guide efforts to ensure reliability and maintainability of equipment, processes, utilities, facilities, controls, and safety/security systems.
• Define, design, develop, monitor, and refine an Asset Maintenance Plan including preventive maintenance tasks and predictive testing methodologies.
• Develop engineering solutions to repetitive failures and other issues affecting plant operations using data analysis tools such as Statistical Process Control, Reliability modeling, Fault Tree Analysis, Six Sigma methodology, and Root-Cause Analysis.
• Provide technical support to production, maintenance management, and technical personnel.
• Determine equipment required to meet customer demand and critical process parameters.
• Support manufacturing during critical process development work for scaling to commercial process.
• Perform other duties as required in support of Catalent Pharma Solutions high performance.

Skills

English

Project management

Communication

Team collaboration

Education

Engineering degree

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

PowerPoint

Job description

Catalent’s Winchester, KY site is a flagship U.S. manufacturing location for large‑scale oral solid dose forms. We seek a Process Engineer to lead projects that advance safety, efficiency, quality, and compliance on onsite capital projects and new product introductions.

The role collaborates across teams to deliver results, with a Monday–Friday 8 AM–5 PM schedule, onsite in Winchester. Ideal candidates bring engineering degree and a background in manufacturing with cGMP knowledge.