The Principal Packaging Engineer leads and coordinates all packaging related work for the Specialty Brands segment of Mallinckrodt Pharmaceuticals. The individual serves as the corporate subject matter expert for packaging new and existing drug substances, drug products and medical devices. This includes the design, specification, testing, qualification and validation of primary packaging, secondary packaging and unitized loads for liquid, solid and gaseous products and sensitive mechanical equipment. The individual also works closely with Transportation personnel to assure reliable, compliant and cost-effective delivery of high-quality products. This position can be located in St. Louis, Mo, Madison WI or Bedminster, NJ areas.
- Self-perform and provide oversight to the design, specification, testing, qualification and validation of packaging systems that include glass vials, thermoform plastic trays, folding cartons, expanded foam, corrugated shippers, pallets and cold chain packaging systems. Less frequently seen packaging types could include drums, flexible intermediate bulk containers (FIBCs), plastic bottles and/or blister packaging.
- Self-perform and provide oversight to the development and execution of testing protocols (including material performance/compatibility, container closure integrity, product stability and distribution hazards), engineering studies and design of experiments. Interpret test results. Author and review reports summarizing test findings and recommendations.
- Maintain a current shipping qualification protocol (to include design, operation and performance qualification steps) per current regulatory requirements and industry guidance (USP, WHO, FDA, etc.).
- Manage qualificationwork in accordance with a pharmaceutical quality system.
- Assure compliance and educate internal customers on applicable pharmaceutical and packaging requirements including industry-recognized standards, industry guidance and test methods (ASTM, ISTA, ISO, USP, ICH, etc.).
- Act as an internal consultant on ad hoc operational issues related to package design and integrity.
- Support savings initiatives by identifying, testing and validating more cost-effective packaging and shipping solutions.
- Develop packaging specifications, drawings and 3D models for packaging components.
- Interface with packaging equipment and component suppliers to assure the technical needs of Mallinckrodt manufacturing facilities are met on a consistent basis.
- Manage packaging-related projects from the conceptual stage through closeout, maintaining tight control of scope, schedule and budget.
Education / Experience / Skills:
- Bachelor of Science in Packaging Science, Mechanical Engineering or other Engineering discipline.
- A minimum of 8 years of packaging engineering experience, preferably in the pharmaceutical, biologics, medical device or related industry.
- Knowledge of regulatory requirements and industry standards relative to packing and shipping pharmaceutical industry products is essential.
- Excellent communication, relationship building and cross-functional collaboration skills are essential.
- The ability to prioritize, schedule and manage multiple concurrent projects is essential.
- Excellent written communication skills are necessary to author testing protocols, reports and packaging sections on NDAs and ANDAs.
- Experience with cold chain shipping and insulated parcel shipping qualification is a plus.
- Hands-on experience with filling machines, packaging equipment and packaging laboratory test equipment is a plus.
- Experience with Solid Works, Artios CAD, Tops and/or comparable software packages is a plus.
- Drive Innovation: Initiates new ideas and builds upon the ideas of others; demonstrates and encourages innovation and continuous improvement
- Understand and Applies Strategy: Operationalizes and executes the strategy in their role and throughout the organization; sets strategy or goals aligned with expertise; drives MNK strategy internally and externally
- Work Efficiently: Makes sound recommendations and ensures time, scope of work and appropriate resources are aligned to achieve high performance
- Be Deliberately Inclusive: Encourages others to contribute; collaborates and shares knowledge amongst peers; helps lead and seeks out cross functional opportunities
- Build Trust: Inspires trust through actions; identifies opportunities to build and model trust within and across functions; actively promotes an environment of trust across functions through consistent words and actions
- Make Effective, Efficient Decisions: Understands the wider impact of their decisions on the department/function/organization/business partners; is able to make decisions under pressure; can make effective decisions without having all the information
The Principal Packaging Engineer works on multi-discipline teams with a broad range of internal personnel including R&D, Regulatory Affairs, Marketing, Manufacturing, Engineering and Transportation. The individual will also interface with external parties including contract manufacturers, package testing laboratories and packaging equipment manufacturers. The position reports to the Sr. Director, Brands Engineering.
Majority of work in normal office setting. A significant portion or work involves operating equipment in a package testing laboratory. Some work around machinery in a manufacturing environment. Travel will vary from 5% to 25% annually.