Senior Packaging Engineer – Primary Packaging

• Perform technical assessments and comparisons between sending and receiving manufacturing sites.
  
• Evaluate bulk tablet handling processes and finished product packaging operations.
  
• Support engineering batches, packaging line trials, and process validation activities.
  
• Lead and support quality investigations, including:
  
  • Root Cause Analysis (RCA)
    
  • Product impact assessments
    
  • Corrective and Preventive Actions (CAPA)
    
• Review change controls and evaluate associated risks, impacts, and required project deliverables.
  
• Conduct technical evaluations to determine potential impacts on:
  
  • Product quality
    
  • Regulatory compliance
    
  • Product stability
    
  • Supply continuity
    
• Develop, review, and maintain primary packaging material specifications.
  
• Resolve technical discrepancies between supplier specifications and company requirements.
  
• Collaborate with global cross-functional teams, suppliers, manufacturing, engineering, quality, and project stakeholders.
  
• Provide technical leadership and additional project support to achieve business and project objectives.
  

Requirements

• Bachelor's degree Completed. 
  
• Minimum of 5 years of relevant experience in Packaging Engineering, primary packaging, or a related technical function within a regulated industry.
  
• Strong expertise in primary packaging materials and primary packaging processes.
  
• Experience within the pharmaceutical, biotechnology, medical device, or other highly regulated industry.
  
• Demonstrated experience supporting packaging operations, engineering batches, line trials, and/or process validation.
  
• Experience conducting or supporting quality investigations, Root Cause Analysis, CAPA, and change controls.
  
• Experience developing, reviewing, or managing material specifications and supplier requirements.
  
• Strong understanding of GMP and regulated manufacturing environments.
  
• Ability to independently perform technical assessments and make risk-based recommendations.
  
• Strong analytical, problem-solving, technical writing, and communication skills.
  
• Ability to collaborate effectively with global and cross-functional teams.
  
• Ability to quickly integrate into an established project team and provide immediate technical support.
  

Preferred Qualifications

• Previous experience serving as a Technical Owner, Packaging SME, Packaging Engineer, or similar technical role.
  
• Experience with site-to-site product or packaging transfers.
  
• Experience evaluating bulk tablet handling and finished product packaging operations.
  
• Strong knowledge of packaging material specifications, supplier management, and packaging-related quality requirements.
  
• Experience supporting pharmaceutical solid oral dosage products is highly desirable.
  
• Located in Puerto Rico, preferably near Gurabo and/or Guaynabo.
  
• Availability for on-site collaboration as required.