Project Engineer Jobs

About The Position

Requirements

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering
• 5+ years of relevant experience with the pharmaceutical industry, or 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 Food and Drug Administration (FDA) regulations and Good Manufacturing Practice (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 and manage complex capital initiatives.
• Excellent communication, organizational, and problem-solving skills.

Responsibilities

• Support internal and external audits.
• Prepare project procurement plan, perform project tendering and procurement.
• Lead design, installation, qualification, and lifecycle support of Isotopes API manufacturing equipment.
• Serve as subject matter expert for new equipment supporting the API expansion capital project.
• Own equipment change management to maintain validated state and Good Manufacturing Practice compliance.
• Investigate equipment and process deviations, performing root cause analysis and implementing corrective and preventive actions.
• Support regulatory inspections and internal audits as engineering subject matter expert.

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.