Sr. Blister Packaging Engineer

APHENA PHARMA SOLUTIONS-TENNESSEE LLC•Cookeville, TN

3d•Onsite

About The Position

Aphena Pharma Solutions is growing, and we’re looking for an experienced Senior Blister Packaging Engineer to lead the design, validation, and continuous improvement of blister packaging systems for pharmaceutical products. This role is a key technical leadership position with real ownership, visibility, and influence across engineering, quality, operations, and customer teams. If you enjoy solving complex packaging challenges, working in a regulated environment, and seeing your work move from concept to production, this role offers the chance to make a real impact.

Requirements

Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Chemical Engineering, or related field (Master’s preferred)
7+ years of experience in pharmaceutical or regulated packaging engineering, with a strong focus on blister packaging
Hands-on experience with thermoforming and cold-form blister processes
Strong working knowledge of cGMP, FDA regulations, and packaging validation
Experience supporting FDA and EMA regulatory submissions
Familiarity with child-resistant and senior-friendly packaging standards
Experience with serialization, vision inspection, and track-and-trace systems
Strong written and verbal communication skills

Nice To Haves

Lean Manufacturing or Six Sigma certification is a plus

Responsibilities

Lead the design, review, optimization, and qualification of blister formats including PVC, PVDC, Aclar®, Alu-Alu, and cold-form structures
Track and manage blister tooling portfolios and support RFQs for new applications
Develop packaging solutions that meet stability, product protection, child-resistant, senior-friendly, and tamper-evident requirements
Partner closely with Sales, Quality, Regulatory, and Manufacturing to align packaging designs with customer and regulatory needs
Serve as the subject matter expert for blister packaging equipment, including thermoform and cold-form systems, tooling, feeders, sealing stations, and vision systems
Support equipment selection, FAT/SAT, installation, commissioning, and optimization
Troubleshoot forming, filling, sealing, print quality, and reject system issues
Drive OEE improvements, scrap reduction, and throughput optimization
Author and review URS, FMEAs, protocols, reports, SOPs, and work instructions
Ensure compliance with cGMP, FDA, EU GMP, ISO 9001, ISO 13485, and internal quality systems
Support regulatory submissions, audits, and inspections related to blister packaging
Evaluate and qualify blister materials, suppliers, and tooling vendors
Support material compatibility studies, seal integrity testing, and stability programs
Manage technical communication with external vendors and contract manufacturing partners
Provide technical guidance and mentorship to junior engineers and technicians
Lead cross-functional teams for packaging projects and continuous improvement initiatives
Act as the technical escalation point for complex blister packaging challenges