Senior Process Engineer

Overview

A fast-growing pharmaceutical manufacturing organization focused on supporting the development and manufacturing of sterile injectable drug products is seeking an experienced Senior Process Engineer to join the team, who is ready to utilize their knowledge within the sterile drug product filling operations, thrives in dynamic environments, excels at technical challenges, and is passionate about building robust, efficient, and scalable manufacturing processes.

Job Responsibilities

• Monitor and analyze manufacturing and equipment performance data to drive continuous improvement and support investigations.
• Lead implementation and execution of standardized decontamination protocols across filling and packaging lines.
• Mentor team members on process improvements, sterilization technologies, equipment requalification, and aseptic practices.
• Lead technical investigations using structured problem-solving methodologies (e.g., DMAIC, root-cause analysis).
• Act as the primary technical representative on cross-functional teams to resolve deviations, equipment failures, and process challenges.
• Evaluate and integrate new technologies such as advanced sterilization or automated filling systems into GMP operations.
• Develop and author protocols, reports, technical rationales, and documentation supporting qualification, validation, and lifecycle activities.
• Adapt quickly to evolving client and production needs, including occasional support for 24/7 operations.

Job Requirements

• Minimum 5 years of experience in a pharmaceutical manufacturing environment.
• Bachelor’s degree or higher in an engineering discipline.
• Strong background in pharmaceutical sterile manufacturing operations.
• Proven ability to communicate complex technical information clearly to cross-functional or non-technical audiences.
• Familiarity with data analytics, root-cause methodologies, and risk-based decision making.