- Support the design of innovative packaging concepts for complex projects, including new product launches and existing products throughout all stages of product development from concept to launch.
- Execute Packaging Validation which includes: IQ, OQ, PQ, protocol writing, execution and documenting final validation result, transportation simulation, accelerated aging, distribution scenarios, external global regulatory requirements, sterilization validation strategies for new products, supporting manufacturing changes.
- Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field
- Recommend, develop and implement manufacturing related cost saving initiatives (Value Improvement Projects).
- Facilitate transitional activities on packaging materials to reduce overall cost and increase throughput. This will include working with Purchasing and raw material suppliers to determine optimal design and material selection.
- Assist as a technical expert in the resolution of problem investigations concerning packaging components.
- Prepare financial justification and evaluation of new packaging machinery proposals.
- Train other packaging personnel on processes, materials etc.
- Confer with vendors to determine product specifications and arrange for purchase of equipment, materials or parts and evaluate products according to specifications and quality standards.
- Work in conjunction with Maintenance Department to identify, recommend and implement the upgrade and automation of current equipment and the purchase of new equipment within regulatory requirements.
- The ability to work independently is essential in this role, which includes management of multiple projects simultaneously within project timelines.
- Lead functional and cross-functional teams to achieve project goals.
- Mentor junior manufacturing engineers in project management activities
- Bachelor’s degree in Engineering (packaging preferred), plus directly related experience (required).
- Master’s degree with emphasis in mechanical, electrical, or industrial engineering (preferred).
- Three (3) - Five (5) years packaging experience in a FDA/GMP regulated industry (pharmaceutical, medical devices or food).
- Proficient in AutoCAD, SolidWorks, Minitab, Word, Excel and Project
- Experience in the application of statistical techniques such as statistical process control, design of experiments, and problem-solving techniques is required. ·
- Experience with design, review, execution, and approval of Installation, Operation and Process Qualification protocols and reports (IQ/OQ/PQ)
- Excellent verbal and written communication skills
- Proven record of delivering multi-disciplinary projects on time and on budget.
- Ability to apply statistical methods to process analysis.
- Define problems, collect data, establish facts, and draw valid conclusions
- Write reports, business correspondence and procedure manuals
- Ability to lead cross-functional/department teams
- Ability to prioritize for maximum results (multi-task management)
- Effective multi-channel communicator
- Function successfully in a high paced results-oriented environment
Argon Medical is a global manufacturer of specialty medical products, headquartered in Frisco, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. By utilizing a well-established sales and marketing infrastructure, Argon serves its global customers through a direct sales organization and through long-standing relationships with medical device distributors, strategic partners and OEMs.
With over 800 employees worldwide, Argon has manufacturing facilities located in Athens, Texas, Wheeling, IL and Rochester, NY.
Role: Packaging Engineer
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