Principal Engineer; Filling

Principal Engineer (Filling)

A high‑level engineering opportunity in Pleasant Prairie, Wisconsin for a Principal Engineer in Filling operations. The role focuses on aseptic filling, sterilization, and sterile drug product handling within a regulated manufacturing environment. It involves leading advanced pharmaceutical manufacturing processes, driving improvement initiatives, ensuring equipment reliability, mentoring junior engineers, and collaborating with cross‑functional teams.

• Provide technical leadership in aseptic filling, sterilisation, and sterile drug product manufacturing processes.
• Monitor process performance using data analysis and drive continuous improvement initiatives.
• Ensure equipment reliability, calibration, and maintenance activities meet regulatory requirements consistently.
• Lead root cause analysis for production issues and implement effective corrective actions.
• Support audit readiness and act as a key technical contact during regulatory inspections.
• Develop and manage capital project scopes and support technology transfer initiatives.
• Identify process bottlenecks and recommend improvements aligned with business objectives.
• Review technical documentation for accuracy and compliance with engineering standards.
• Mentor junior engineers and support training across manufacturing and quality teams.
• Collaborate with cross functional teams including quality assurance and manufacturing operations.

• Bachelor’s degree in Engineering or related technical discipline is required.
• At least eight years of senior engineering experience in pharmaceutical manufacturing environments is required.
• Minimum five years of aseptic filling operations experience in regulated industries is required.
• Strong understanding of regulatory compliance standards within pharmaceutical manufacturing is required.
• Experience in equipment troubleshooting and process validation is highly preferred.
• Proven ability in technical leadership, problem solving, and project management is required.
• Strong communication skills for cross‑functional collaboration and documentation review are required.
• Experience with manufacturing execution systems and quality management systems is preferred.
• Ability to manage multiple priorities in a fast‑paced production environment effectively is required.

This role offers a strong platform for senior engineers seeking leadership in pharmaceutical manufacturing innovation.