Sr Project Engineer

About the role

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.

Responsibilities

• Contribute to project planning.
  
• Lead assigned workstreams.
  
• Support regulatory compliance.
  
• Provide hands-on engineering support from design through execution.
  

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 finished 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.
  
• Able to lead cross-functional teams and manage complex capital initiatives.
  
• Excellent communication, organizational, and problem-solving skills.
  

Qualifications

• Not specified.
  

Skills

• Not specified.
  

Benefits

• Comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
  
• Generous time off package including vacation, personal days, holidays and other leaves.
  

Pay

The salary for this position is expected to range between $93,800 and $174,200 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Schedule

Not specified.