Sr. Blister Packaging Engineer

# Sr. Blister Packaging Engineer Fisk - Aphena Pharma Solutions TN - Cookeville, TN 38506## Overview Position Type Full Time Job Shift Day Education  Level4 Year Degree

Travel Percentage None Category Manufacturing ## Description 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.

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** 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## Qualifications###
** What 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.

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** Benefits
* ** Competitive pay
* Medical, dental, and vision insurance
* 401(k) with company match
* Paid time off and holidays
* Career development and growth opportunities
* Clean, climate-controlled manufacturing environment
* Relocation assistance may be available for qualified candidates
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