Senior Process Engineer (Filling)

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.

In this role, you will lead and support process improvement initiatives, equipment lifecycle activities, validation efforts, and cross-functional investigations. You will also serve as a technical resource for aseptic operations, decontamination systems, sterilization technologies, and advanced filling equipment. This position is ideal for someone who enjoys hands-on work, cross-functional collaboration, and contributing to a high-growth, high-impact manufacturing operation.

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.
• Conduct and support process risk assessments (FMEA) for equipment, containment systems, and aseptic environments.
• Mentor team members on sterilization technologies, equipment requalification, and aseptic practices.
• Ensure successful execution of process comparability, validation, and engineering studies by assessing risk, troubleshooting equipment issues, and establishing preventive controls.
• 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.
• Execute validation test cases, recipe development, and engineering studies for aseptic filling lines, packaging systems, and controlled environments.
• Collaborate with external partners to define system requirements and verify performance of sterilization, decontamination, and environmental control systems.
• 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.
• Hands-on experience with autoclaves, VHP systems, decontamination technologies, and equipment requalification.
• Strong background in aseptic or 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.

Preferred Qualifications

• Experience in a contract manufacturing (CMO / CDMO) environment.
• Technical certifications such as Lean Six Sigma or equivalent.
• Experience working with isolator technology, advanced filling systems, or robotics.
• Strong technical writing and documentation capabilities.