Lead Process Engineer - Kenosha - Brooksource

    Brooksource
    Brooksource Kenosha

    12 hours ago

    $135,000 - $195,000 (USD) per year *
    Description

    Lead Process Engineer – Pharmaceutical Manufactruing

    Location: Kenosha, WI

    Partnered Through: Brooksource Engineering Services

    Client: Pharmaceutical Manufacturing Client

    Summary

    Brooksource Engineering Services is seeking a Lead Process Engineer to provide technical leadership across aseptic manufacturing, device assembly, and packaging operations. This role owns process reliability, troubleshooting, equipment performance, and continuous improvement for multiple regulated manufacturing areas.

    The ideal candidate is a hands-on engineer who excels at floor support, cross-functional collaboration, and driving structured improvements in high‑speed, highly regulated production environments.

    Key Responsibilities

    Aseptic Manufacturing (Filling, Isolators, Sterile Systems)

    • Serve as SME for aseptic equipment and processes, ensuring compliance, reliability, and qualified state.
    • Provide daily floor support to address downtime, operator challenges, and process deviations.
    • Lead problem solving, root cause analysis, and corrective actions for recurring or high‑impact issues.
    • Support and lead equipment qualification (IQ/OQ/PQ) for new or modified systems.

    Device Assembly (Injectors, Pens, Combination Products)

    • Troubleshoot automated/semi-automated assembly equipment (vision systems, welders, torque tools).
    • Trend performance data, identify bottlenecks, and implement improvements to throughput and reliability.
    • Partner with quality and design teams to support component qualification and meet combination product compliance requirements.

    Packaging (Labeling, Cartoning, Serialization, Kitting)

    • Support high-speed packaging equipment performance and resolve mechanical/automation issues.
    • Improve line efficiency, changeover performance, material flow, and overall equipment effectiveness.
    • Assist in qualifying packaging components, formats, and equipment upgrades.

    Cross-Functional Leadership

    • Mentor junior engineers and provide technical escalation support.
    • Collaborate with operations, quality, maintenance, automation, and vendor partners to ensure stable performance across all manufacturing areas.
    • Manage improvement projects—scope, prioritization, execution, and communication of results.

    Qualifications

    Minimum Requirements

    • Bachelor's in Engineering (Chemical, Mechanical, Industrial, or related).
    • Experience in aseptic pharma, medical device, or regulated manufacturing.
    • Strong troubleshooting capability with automated equipment and production systems.
    • Knowledge of cGMPs, validation, and structured problem-solving.

    Preferred

    • Experience with filling/isolators, device assembly automation, or packaging line engineering.
    • Exposure to IQ/OQ/PQ, change control, and continuous improvement methodologies.
    • Prior leadership or mentorship experience.
    * This salary range is an estimation made by beBee
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