Sr. Blister Packaging Engineer

Aphena Pharma Solutions•Cookeville, TN

1d•$103,500 - $103,500•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. What You’ll Do Blister Packaging Design & Development 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 Equipment & Process Engineering 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 Validation & Compliance 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 Materials & Supplier Management 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 Leadership & Mentorship 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 QualificationsWhat We’re Looking For 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 Lean Manufacturing or Six Sigma certification is a plus Physical & Work Environment Work in manufacturing and cleanroom environments Frequent time on the production floor with standing and walking Ability to manage multiple projects and deadlines Strong written and verbal communication skills Occasional off-shift or weekend support as needed Why Aphena? At Aphena, people matter. We’re a growing pharmaceutical packaging organization where collaboration, accountability, and doing the right thing are more than words on a wall. Engineers here have a voice, real ownership, and the opportunity to influence decisions that affect quality, safety, and performance. You’ll work with experienced teams, modern equipment, and leadership that values expertise and practical problem-solving. If you’re looking for a place where your knowledge is respected and your work truly matters, you’ll feel at home here.

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
Ability to manage multiple projects and deadlines
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