Lead Process Engineer

Lead Process Engineer – Pharmaceutical Manufactruing
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.

• 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.
• 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.

• 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.

• 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.

• 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.

• 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.