Automated Combination Product Assembly Engineer 

Location: New Albany, OH

Duration: 12 months (Possible extension)

Key Responsibilities:

1. Project Management:

   • Support Technical Transfer of the product portfolio 
   • Provide technical operations support for continuous improvement of device assembly and packaging line capacity.
   • Advise on technical improvement projects and ensure effective communication across the Ohio commercial site and network.

2. Technical Leadership:

   • Act as the site technical expert for automated and semi-automated device assembly for FDP and non-combination products.
   • Lead Commissioning, Qualification, and Validation of process and GMP equipment 
   • Own the site master validation plan for GMP equipment.

3. Operational Excellence:

   • Support delivery of productivity, throughput, and capacity improvements across the site.
   • Analyze, design, and implement manufacturing and business process improvements.

Relationships:

Build a network of FDP expertise across commercial and clinical operations. Leverage this network to support GMP technical expertise, performance trending, equipment standardization, and troubleshooting/process improvements .

Minimum Requirements:

Education/License:

• Master’s degree and/or 2 years of working in a GMP regulated environment.
• Bachelor’s degree and/or 5 years of working in a GMP regulated environment.

Competencies/Skills:

• Knowledge of combination product assembly equipment and applicable testing.
• Excellent written and verbal communication skills, with a proven ability to work in a team environment.
• Track record of leading and executing cross-functional projects.
• Direct experience with the manufacturing process for devices, combination products, and label & packaging operations.
• Experience working with Final Drug Product equipment suppliers.
• Ability to work in a highly regulated and ever-changing industry.
• Operational Excellence approach to work – driving rapid results.
• Passion for delivering an excellent work product and developing others with an infectiously positive attitude.

Top 3 Must-Have Skill Sets:

1. Knowledge of combination product assembly equipment and applicable testing.
2. GMP process equipment design, testing, characterization, and validation.
3. Will work on packaging and medical device equipment.