Packaging Engineer

Ultimate Solutions Corp; Puerto Rico; On-site; USD 90,000 - 120,000; Full time

Job summary

Ultimate Solutions Corp is seeking a seasoned packaging engineer with at least 5 years in FDA-regulated industries such as Pharmaceutical or Medical Device. The role emphasizes primary packaging development, container/closure systems, and cold chain considerations across global markets.

Responsibilities include leading packaging projects, providing technical support for new drug products, and collaborating with research and operations to drive improvement.

Qualifications

• Minimum 5 years in Pharmaceutical, Medical Device, or FDA-regulated industry.
• Experience in design and development of primary packaging systems for solid dosage forms.
• Familiarity with worldwide regulations to support container and packaging development.
• Ability to interface effectively with research, operations, and external suppliers.

Responsibilities

• Packaging Area experience.
• Experience in C&Q process, Validation 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.

Skills

Packaging Area Experience

C&Q Process & Validation

Education

BS Degree in Engineering

Job description

Description

The successful candidate must have minimum 5 years' experience in Packaging areas for regulated environment industries such as Medical Device, Pharmaceutical, Bio-pharmaceutical or other FDA regulated industry.

Responsibilities

• Packaging Area experience
• Experience in C&Q process, Validation 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.

Experience

Minimum 5 years of 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 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.

Education

Minimum of a BS Degree in Engineering field.

Ultimate Solutions Corp is an Equal Opportunity Employer.