Project Engineer

Flexible & Integrated Technical Services, LLC•Añasco, PR

10d•Onsite

About The Position

This role is for Validation services in the Project Engineering/Medical Device Packaging area. The ideal candidate will support packaging validation and testing activities for sterile and non-sterile medical device packaging systems. This includes assisting senior engineers, collecting and analyzing data, preparing technical documentation, and coordinating with cross-functional teams. The role also involves supporting troubleshooting, risk assessments, and ensuring compliance with regulatory requirements.

Requirements

Bachelor’s Degree in Engineering
At least four (4) years of exposure to Validation Engineering activities within the Pharmaceutical or Medical Devices industry.
Bilingual (Spanish and English)
Experience in Packaging validation and testing activities for sterile and non-sterile medical device packaging systems.
Experience in Engineering documentation, data collection, technical reports, protocols, specifications, and change records.
Experience in Manufacturing processes, engineering concepts, and problem-solving methodologies.

Nice To Haves

FDA QSR, ISO 13485, ISO 9001, GMP environments, MDR, and CMDR requirements
Validation activities, laboratory testing, statistical analysis, and risk assessments
Medical device packaging systems, sterile barrier systems, and validation methodologies

Responsibilities

Support packaging validation and testing activities for sterile and non-sterile medical device packaging systems.
Assist senior engineers in the execution of packaging studies, validation protocols, engineering evaluations, and testing activities.
Collect, organize, analyze, and document testing data to support validation efforts and engineering decision-making.
Support engineering activities including setup, sample preparation, data collection, and documentation tasks.
Prepare and maintain technical documentation such as protocols, reports, test summaries, specifications, and change records.
Coordinate activities with cross-functional teams including Quality, Operations, Regulatory Affairs, and Product Development.
Support troubleshooting efforts related to packaging performance, manufacturing processes, or testing issues.
Assist with risk assessments, continuous improvement initiatives, and process optimization projects.
Ensure compliance with internal procedures and applicable regulatory requirements including FDA QSR, ISO 13485, ISO 9001, MDR, and CMDR.
Maintain accurate project records and support the timely completion of assigned deliverables.
Participate in packaging line trials, validation builds, and manufacturing support activities.
Provide on-site support across different shifts and weekends as required by project and operational needs.
Demonstrate initiative, accountability, flexibility, and willingness to learn new technical skills and regulatory requirements.