Salary
💰 $126,500 - $199,100 per year
About the role
- Lead or participate in capital equipment projects, developing network equipment & process standards, solving complex packaging process and equipment issues, optimizing processes, and ensuring compliance
- Collaborate with site-based and above-site based functional teams to achieve company goals
- Develop and implement equipment standards across multiple manufacturing or packaging sites
- Manage packaging equipment purchases, transfer/relocation, and device component source changes; support site operations and launches
- Serve as packaging SME for above-site packaging and assembly equipment; provide technical support for troubleshooting and performance analysis
- Apply packaging science/engineering concepts (mechanical/electrical, automation, validation, Lean/Six Sigma, GMP, serialization) to resolve issues
- Coordinate with Serialization CoE on serialization strategy and implementation across sites
- Establish packaging equipment specification standards in line with company principles across multiple packaging platforms
- Evaluate new technologies for compatibility with existing lines and collaborate with site technology groups
Requirements
- Education minimum: Bachelor’s degree in Packaging Science/Engineering, Mechanical Engineering, or related technical discipline
- Minimum of 10 years’ experience in the pharmaceutical, biotechnology, or medical device industry, with at least 3-5 years in a leadership role
- Strong background in the medical device, combination product, pharmaceutical packaging equipment and operational process and related scientific/technical concepts
- Broad experience with devices and combination products, covering design control to product and technology transfer for both new and existing packaging facilities
- Exceptional project management skills, from conception and initiation, through project close-out
- Thorough knowledge and proven expertise in GMP application and quality systems, particularly in process and equipment qualification & validation, root cause analysis, change control, deviation management, and cleaning qualification
- Proficiency in mechanical & electrical knowledge, automation, AutoCAD/SolidWorks, Lean/Six Sigma, serialization, VOC, process capability, RCA
- Extensive experience with quantitative decision tools for root cause analysis, risk management and options analysis
- Strong leadership, collaboration, and communication skills; ability to operate autonomously