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.