Process Engineer

Catalent - Winchester, VA

Full-time - Entry Level

Winchester, VA

10,001+ employees

Chemical Manufacturing

About the position

The Process Engineer at Catalent plays a crucial role in the Site Engineering Team, focusing on process and equipment improvement, as well as conducting root cause analysis for process deviations. This position is integral to ensuring the efficiency and compliance of manufacturing operations at Catalent's flagship US facility, which specializes in complex controlled release oral dose forms. The role involves monitoring equipment performance, implementing process improvements, and collaborating with various teams to support the design and operation of facility and process equipment.

Responsibilities

• Create and monitor key equipment performance metrics such as equipment downtime and reject trends.
• Use statistical thinking and methods to understand process variability and capability and drive process improvements.
• Determine process capabilities and bottlenecks, implement improvements, and develop contingency plans for capacity/productivity increases.
• Identify failure modes of equipment and maintenance strategies to mitigate the impact of failure.
• Responsible for the design and implementation of process systems, ensuring compliance with cGMP expectations.
• Work with operations, validation, process development, and quality functions to support the design, installation, start-up, validation, and operation of facility and process equipment.
• Assist in synchronizing site functions through all phases of process improvements including new assets.
• Ensure compliance with Health, Safety, and Environmental requirements throughout the project.

Requirements

• Minimum Bachelor's degree in mechanical, chemical, or electrical engineering or working towards completing a Bachelor's degree.
• Ability to communicate effectively with engineers, technicians, customers, staff, and other personnel.
• Ability to provide detailed documentation in support of projects, including business case analysis based on historical data or industry standards.
• Ability to troubleshoot simple to complex process and equipment problems.
• Knowledgeable in the operation of common handheld and specialty tools and equipment.

Nice-to-haves

• Experience in a pharmaceutical manufacturing environment.
• Familiarity with cGMP regulations and compliance standards.
• Strong analytical and problem-solving skills.

Benefits

• Tuition Reimbursement
• Generous 401K match
• 152 hours accrued PTO + 8 paid holidays
• Opportunities for career advancement