Sr. Packaging Engineer

Flexible & Integrated Technical Services, LLC • Juncos, PR

3d

About The Position

FITS is seeking a Senior Packaging Engineer to support a leading biotechnology manufacturer in validation services and engineering. The role serves as a technical expert on packaging materials, selecting, testing, and qualifying primary and secondary packaging components and leading projects from evaluation through implementation. The position also involves distribution testing, packaging validation, troubleshooting, technical documentation, project coordination, and collaboration with manufacturing and other regulated-industry teams. The shift is administrative and according to business needs.

Requirements

• Doctorate, or a master's degree plus at least 2 years of engineering experience, or a bachelor's degree in Engineering plus at least 4 years of engineering experience.
• Project management skills.

Nice To Haves

• Packaging engineering experience in pharmaceutical or biotechnology final-product manufacturing.
• Strong knowledge of GMP and GDP.
• Knowledge of primary and secondary packaging materials, including bottles, labels, trays, lidding, leaflets, paperboard, sterile barrier packaging, and corrugated materials.
• Familiarity with ASTM D4169 distribution testing and ASTM, ISO, TAPPI, USP, and EP standards.
• Experience writing test protocols and performing technical evaluations to support packaging material selection.
• Ability to work as a team player and adapt well to change.

Responsibilities

• Lead the evaluation, selection, and qualification of primary and secondary packaging materials and components.
• Design and conduct distribution testing according to ASTM D4169 and ISTA, then analyze and report results.
• Write test protocols and technical reports supporting material and component selections.
• Support line trials and packaging validation before new components or changes are introduced.
• Troubleshoot packaging component issues and lead investigations involving production, the warehouse, and incoming inspection.
• Develop engineering techniques and procedures for complex or novel assignments.
• Develop engineering procedures affecting multiple organizational units.
• Supervise, coordinate, and review the work of engineers, associates, and technicians.
• Serve as a recognized packaging technical specialist and determine methodologies in that area.
• Partner with Manufacturing, Process Development, Quality Assurance, Validation, Facilities, and suppliers on packaging requirements and modifications.
• Coordinate consultants, vendors, and engineering firms on design documents and project deliverables.
• Work with project managers to deliver projects on schedule, within budget, and to quality standards.
• Develop project budgets and use financial analysis tools to support project decisions.
• Manage change controls and document work in compliance with GMP and GDP.

Benefits

• Opportunities to work on high-impact projects with a leading biotechnology manufacturer in Puerto Rico.
• Opportunities to grow a career across FITS’ network of clients in pharmaceutical, biotechnology, and medical-device industries.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior