Job Description

For Validation services in the Engineering area.

What Makes You A Fit:

FITS is looking for a Senior Packaging Engineer to support a leading biotechnology manufacturer. You’ll be the technical expert behind the materials that protect the product: selecting, testing, and qualifying primary and secondary packaging components, and leading projects from evaluation to implementation. If you know packaging materials inside out and enjoy proving your decisions with data, this role is for you.

• One of the following:
• a Doctorate,
• a Master’s plus 2+ years of engineering experience, or
• a Bachelor’s in Engineering plus 4+ years of engineering experience
• Shift: Administrative, and according to business needs.
• Project Management Skills

The Preferred Qualifications:

• Packaging engineering experience in Pharma/Biotech final product manufacturing
• Strong GMP and GDP knowledge
• Knowledge of primary and secondary packaging materials: bottles, labels, trays, lidding, leaflets, paperboard, sterile barrier packaging, and corrugated
• 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
• Team player who adapts well to change

As a Piece You Will: (The day-to-day on the job)

• Lead the evaluation, selection, and qualification of primary and secondary packaging materials and components
• Design and run distribution testing per ASTM D4169 and ISTA, and analyze and report the results
• Write test protocols and technical reports that justify material and component choices
• Support line trials and packaging validation before new components or changes are introduced
• Troubleshoot packaging component issues, and lead investigations across production, the warehouse and incoming inspection
• Develop new and improved engineering techniques and procedures for complex or novel assignments
• Develop engineering procedures that affect multiple organizational units
• Supervise, coordinate, and review the work of engineers, associates, and technicians
• Serve as a recognized technical specialist in packaging, and determine the methodology 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.

Being a FITS Piece Comes With Perks

• Work on high-impact projects with one of Puerto Rico’s top biotechnology manufacturers
• Opportunities to grow your career across FITS’ network of clients in pharma, biotech, and medical devices

Who We Are

FITS is a Puerto Rico-based engineering and technical firm. We connect skilled professionals with leading companies in regulated industries, including pharmaceutical, biotech, medical device, and manufacturing. We believe the right talent fits like the right piece, and we work to make every placement a lasting match.