Senior Packaging Engineer – Primary Packaging

We are seeking a highly experienced Primary Container Technical Owner with extensive expertise in primary packaging materials, packaging processes, and technical project support within a regulated pharmaceutical or medical device environment. The ideal candidate will be able to work independently, integrate quickly into an existing project team, and provide immediate technical leadership.

Responsibilities:

• 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.