Job Summary

• Support the delivery of capital initiatives, continuous improvements/ upgrades to isolator containment systems, and the implementation of new manufacturing technologies within a GMP-regulated environment.
• Lead design, installation, qualification, and lifecycle support of Isotopes API manufacturing equipment and serve as subject matter expert for new equipment.
• Investigate equipment and process deviations, performing root cause analysis and implementing corrective and preventive actions, while supporting regulatory inspections and internal audits.

Matching Summary

Salary

Base: $93,800 - $174,200; Bonus/Equity: Performance-based cash incentive and eligibility for annual equity awards; Benefits: Comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, generous time off

Skills & Requirements

Key Requirements

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering
• 5+ years of relevant experience with the pharmaceutical industry
• 8+ years of relevant experience within the pharmaceutical industry in lieu of a degree
• Extensive experience supporting API and/or finish drug product manufacturing
• Strong expertise with Hot cells / Isolator Containment systems
• In-depth knowledge of FDA regulations and GMP requirements
• Experience leading equipment qualification, validation strategies, and change management
• Strong technical writing skills for regulated engineering documentation
• Ability to lead cross-functional teams

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