Packaging Validation Engineer — Medical Devices

Kelly Services; Añasco (PR); On-site; USD 28,000 - 40,000; Full time

Benefits offered by this job

Weekly pay (W2)

Sick, Vacations & Holidays paid

Christmas bonus

Job summary

Kelly Engineering in Puerto Rico is seeking a Validation Engineer to support sterile and non-sterile medical device packaging validation in a regulated manufacturing environment. The role requires a degree in engineering, GMP/ISO knowledge, and strong documentation skills.

It offers weekly pay and comprehensive benefits in a collaborative setting. The position emphasizes hands-on testing, protocol execution, cross-functional coordination, and continuous improvement within ISO-class environments.

Qualifications

• Bachelor's Degree in Engineering or related technical discipline (required).
• Internship, co-op, or academic project experience within medical devices, manufacturing, quality, or packaging is considered as experience
• Experience working in a regulated industry (Medical Device, Pharmaceutical, Biotechnology, etc.). Experience with tray-sealing processes (required).
• Available for working in ISO Class 7 cleanroom environments and following strict gowning requirements.
• Demonstrate strong documentation, organizational, and communication skills.
• Fluent in English (read, write, speak, and understand).
• Proficient in Microsoft Office (Excel, Word, PowerPoint).
• Thrive in a fast-paced, collaborative manufacturing environment with a strong willingness to learn.
• At least 4+ years of engineering or manufacturing experience. (Preferred)
• Experience with packaging validation, laboratory testing, or engineering projects.
• Knowledge of FDA QSR, ISO 13485, ISO 9001, GMP, and medical device regulations.
• Exposure to sterile barrier systems and validation methodologies.

Responsibilities

• Supporting packaging validation and testing activities for sterile and non-sterile medical device packaging systems.
• Executing validation protocols, engineering studies, and testing activities in close collaboration with Packaging and Project Engineers.
• Collecting, analyzing, and documenting testing data and validation results.
• Preparing and maintaining technical documentation, including protocols, reports, and test summaries.
• Coordinating with cross-functional teams such as Quality, Operations, Regulatory, and Engineering.
• Supporting troubleshooting, risk assessments, process improvements, and packaging line trials.
• Ensuring compliance with internal procedures and applicable regulatory requirements.

Skills

Fluent English

Education

Bachelor's Degree in Engineering

Tools

Microsoft Office

Job description

Kelly Engineering in Puerto Rico is seeking a Validation Engineer to support sterile and non-sterile medical device packaging validation in a regulated manufacturing environment. The role requires a degree in engineering, GMP/ISO knowledge, and strong documentation skills.

It offers weekly pay and comprehensive benefits in a collaborative setting. The position emphasizes hands-on testing, protocol execution, cross-functional coordination, and continuous improvement within ISO-class environments.