Automated Combination Product Assembly Engineer
Location
Ohio | United States
Job description
Automated Combination Product Assembly Engineer
Location: New Albany, OH
Duration: 12 months (Possible extension)
Key Responsibilities:
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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.
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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.
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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:
- Knowledge of combination product assembly equipment and applicable testing.
- GMP process equipment design, testing, characterization, and validation.
- Will work on packaging and medical device equipment.
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