Sr. Blister Packaging Engineer

## 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

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### **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

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### **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