Packaging Engineer – Ultimate Solutions – East Area, Puerto Rico
The Packaging Engineer candidate must have experience in Packaging Components areas for regulated environment industries such as Medical Device, Pharmaceutical, Bio-pharmaceutical or other FDA regulated industry.
Duties and Responsibilities:
Provide support and technical expertise in the design, testing, selection and production scale-up of packaging components, packaging systems and packaging equipment. Originate and develop new packaging projects and initiatives that lead to process improvements that have a significant impact across functions. Function as technical team member for the Packaging Development groups within the Consumer Development and Manufacturing Science organization. Provide technical support in the development and commercialization of container/closure systems for new drug products or re-launch involving multiple dosage forms and modifications to marketed products in a global environment. Identify, evaluate, and develop new primary packaging concepts for eventual production use. Includes developing packaging specifications and procedures for solid dose packaging components. Responsibilities include container closure systems, primary packaging components, child resistant requirements, brand protection features, and cold chain transportation systems. Provide guidance to Clinical Packaging and other functions regarding primary and secondary packaging solutions. Support green packaging initiatives as required. Maintain ownership of primary packaging specifications and author pertinent sections of worldwide Regulatory Filings.
Provide support and technical expertise in the design, testing, selection and production scale-up of packaging components, packaging systems and packaging equipment. Originate and develop new packaging projects and initiatives that lead to process improvements that have a significant impact across functions. Function as technical team member for the Packaging Development groups within the Consumer Development and Manufacturing Science organization. Provide technical support in the development and commercialization of container/closure systems for new drug products or re-launch involving multiple dosage forms and modifications to marketed products in a global environment. Identify, evaluate, and develop new primary packaging concepts for eventual production use. Includes developing packaging specifications and procedures for solid dose packaging components. Responsibilities include container closure systems, primary packaging components, child resistant requirements, brand protection features, and cold chain transportation systems. Provide guidance to Clinical Packaging and other functions regarding primary and secondary packaging solutions. Support green packaging initiatives as required. Maintain ownership of primary packaging specifications and author pertinent sections of worldwide Regulatory Filings.
Education:
Minimum of a BS Degree in Packaging Engineering, Mechanical Engineering, Materials Science, Polymer Science or equivalent with a minimum of 5 years experience directly related to Package Development roles OR a Master’s Degree with 3 years , OR PhD with 1 to 3 years’ experience in Package Development roles.
Experience:
Experience in a Pharmaceutical, Medical Device, or other FDA regulated industry or related field are required. Experience in the design, development of primary packaging systems with emphasis on solid dosage forms. Familiarity with worldwide regulations to support container and packages development is required. Knowledge of device development and regulations, as well as, process thinking and continuous improvement tools and principles is a plus. Experience in packaging components and material specifications and qualification activities on a fast passed environment is a must. Must be effective communicator in a team environment with strong interpersonal and analytical skills with the ability to interface effectively with research, operations, and external suppliers and manufacturers. Ability to influence decisions.
Experience in a Pharmaceutical, Medical Device, or other FDA regulated industry or related field are required. Experience in the design, development of primary packaging systems with emphasis on solid dosage forms. Familiarity with worldwide regulations to support container and packages development is required. Knowledge of device development and regulations, as well as, process thinking and continuous improvement tools and principles is a plus. Experience in packaging components and material specifications and qualification activities on a fast passed environment is a must. Must be effective communicator in a team environment with strong interpersonal and analytical skills with the ability to interface effectively with research, operations, and external suppliers and manufacturers. Ability to influence decisions.
