Sr. Blister Packaging Engineer
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Job Location:
Cookeville, TN - USA
Monthly Salary:
$ 103500 - 103500
Posted on:
2 days ago
Vacancies:
1 Vacancy
Department:
Job Summary
Aphena Pharma Solutions is growing and were 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 Youll 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 Were Looking For
- Bachelors degree in Packaging Engineering Mechanical Engineering Chemical Engineering or related field (Masters 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. Were 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.
Youll work with experienced teams modern equipment and leadership that values expertise and practical problem-solving. If youre looking for a place where your knowledge is respected and your work truly matters youll feel at home here.
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
Required Experience:
Senior IC
Key Skills
- Continuous Integration
- Food Industry
- Minitab
- Packaging
- CAD
- Mechanical Knowledge
- Plastics Blow Molding
- SolidWorks
- Mechanical Engineering
- Plastics Injection Molding
- Microsoft Project
- Manufacturing
