Bachelor's degree in chemical, electrical, or mechanical engineering
5+ years pharmaceutical industry experience
Extensive api and finish drug product manufacturing support
This role supports the delivery of capital initiatives and continuous improvements to isolator containment systems within a GMP-regulated environment
Job Summary
This role supports the delivery of capital initiatives and continuous improvements to isolator containment systems within a GMP-regulated environment.
The position requires leading the design, installation, qualification, and lifecycle support of Isotopes API manufacturing equipment while maintaining validated state compliance.
Compensation includes a performance-based cash incentive, potential annual equity awards, and a comprehensive benefits package including health, 401(k), and generous time off.
Matching Summary
This role supports the delivery of capital initiatives and continuous improvements to isolator containment systems within a GMP-regulated environment.
Salary
Base: $93,800 - $174,200 per year; Bonus/Equity: Performance-based cash incentive and eligibility for annual equity awards; Benefits: Health, life, disability, 401(k) match, vacation, personal days, holidays
Skills & Requirements
Must-have
Bachelor's degree in Chemical, Electrical, or Mechanical Engineering
5+ years pharmaceutical industry experience
Extensive API and finish drug product manufacturing support
Strong expertise with Hot cells and Isolator Containment systems
In-depth knowledge of FDA regulations and GMP requirements
Experience leading equipment qualification and validation strategies
Ability to lead cross-functional teams on complex capital initiatives
Nice-to-have
Excellent technical writing skills for regulated documentation
Strong problem-solving and organizational skills
Experience supporting internal and external audits
Root cause analysis and CAPA implementation skills