Location: Indianapolis
Job Summary
As a Senior Packaging Engineer, you will play a crucial role in ensuring the efficiency, maintenance, and enhancement of packaging systems and infrastructure throughout the facility. You will be responsible for overseeing the design and implementation of manual and fully automated packaging systems that support GMP manufacturing processes, particularly for Radiopharmaceuticals at the Indianapolis site.
In this position, you will lead the development and optimization of packaging processes, ensuring compliance with industry standards and regulatory requirements. Your role will involve troubleshooting and resolving issues related to packaging equipment and systems, as well as collaborating with cross-functional teams to support production needs.
You will also assist in the commissioning, qualification, and validation of new packaging equipment, ensuring that all systems are fully operational and meet quality standards. Additionally, you will manage packaging spare parts and contribute to the creation of a Packaging Master Plan for the site, leveraging your technical expertise in packaging technologies, materials, and data management.
Job Responsibilities:
Essential duties and responsibilities include the following. Other duties may be assigned.
- Develop, Design, and Implement Packaging Systems: Lead the development and integration of advanced packaging systems for the Indianapolis site.
- Develop, Design, and create specifications for packaging components & Related Materials: This role will have the responsibility of packaging materials in addition to equipment and will work with supply chain to spec such components as kits, tubes, vials, stoppers, bags, and other equipment necessary for production working with validation to also validate such components and setting of min/max levels with supply chain.
- Develop Testing, Processes, and Consumables: Develop testing such as crush testing for boxes, dye penetrate testing, label affixation testing, burst pressure testing, design of labels, booklets, text on labels, and development of kits for process.
- Documentation Management: Create and maintain detailed documentation for packaging systems, including process flow diagrams, material specifications, and operational protocols.
- System Integration: Collaborate with cross-functional teams to integrate packaging systems with Radiopharmaceutical Hotcells and other production equipment.
- Validation Support: Assist the Validation team in developing and executing test plans to ensure the performance and reliability of packaging systems
- Continuous Improvement: Monitor and optimize packaging processes to enhance reliability and reduce reliance on manual operations.
- Project Leadership: Oversee and manage packaging projects from initial concept through deployment, ensuring timely execution and compliance with pharmaceutical and radiopharmaceutical standards.
- Collaboration: Heavy collaboration with supply chain, regulatory, and quality on final packaging of product and tracking of processes.
Education and Experience:
- Minimum of a BS degree in Mechanical, Industrial, Packaging Engineering, or other applicable science.
- 5-7+ years of experience as a Packaging Engineer
- Experience working in a regulated industry such as radiopharmaceuticals, pharmaceuticals, biotechnology, healthcare, or medical device manufacturing is highly desirable.
- Previous experience with serialization, label printing, label affixing machines, and burst testing of packaging is highly desired.
- Prior experience with a SAP tyle system for supply chain management
Skills and Qualification:
- Highly motivated and organized professional able to work both independently and as part of a team
- Ability to interpret technical drawings, schematics, and manuals for Packaging Systems.
- Strong attention to detail is required
- Very personable with strong communication skills
- Excellent professional ethics, integrity, and ability to maintain confidential information
- Understanding of DOT requirements
- Understanding of QR code and barcode printing on vial, caps, and other consumables
Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and distance vision.
Work Environment:
The noise level in the work environment is usually moderate.
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