Principal Process Engineer – Aseptic Filling Lines Location: Kenosha, WI (Onsite) Company: Brooksource Engineering Services Position Overview Brooksource Engineering Services is seeking a Principal Process Engineer to provide hands-on technical leadership for aseptic filling operations within a GMP-regulated sterile injectable manufacturing environment. This role is focused on deep technical ownership of filling lines, isolators, and related sterile systems, with an emphasis on floor-based engineering support, troubleshooting, and process optimization. This is a true hands-on engineering role, not an operations or documentation-focused position. Key Responsibilities Serve as the technical authority for aseptic filling line performance, reliability, and control. Provide daily on-the-floor engineering support for filling operations, addressing equipment, process, and aseptic execution challenges. Lead advanced troubleshooting of filling equipment, isolators, and sterile transfer systems to minimize downtime and quality risk. Drive root cause analysis and technical corrective actions for recurring deviations and performance losses. Maintain and protect the qualified and validated state of filling equipment and processes. Lead and execute hands-on support for IQ/OQ/PQ and requalification activities for filling lines and system modifications. Partner with automation, maintenance, and quality teams to improve equipment capability and aseptic robustness. Identify, scope, and execute continuous improvement initiatives focused on throughput, yield, and aseptic risk reduction. Mentor engineers and provide escalation-level technical guidance across filling operations. Qualifications Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, or related discipline). Extensive hands-on experience supporting aseptic filling operations in sterile injectable manufacturing. Strong preference for direct production support experience (not limited to qualification or documentation-only roles). Demonstrated expertise troubleshooting filling equipment, isolators, and sterile processing systems. Working knowledge of cGMPs, aseptic processing principles, and validation requirements. Experience with Optima or similar high-speed aseptic filling platforms is a plus. Brooksource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Benefits
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