For Validation services in the Project Engineeirng/Medical Device Packaging area.
WHAT MAKES YOU A FIT: The Technical Part:- Bachelor's Degree in Engineering and at least four (4) years of exposure to Validation Engineering activities within the Pharmaceutical or Medical Devices industry. ,
- Bilingual (Spanish and English)
- Shift: Administrative & according to business needs
- Experience in:
- Packaging validation and testing activities for sterile and non-sterile medical device packaging systems.
- Engineering documentation, data collection, technical reports, protocols, specifications, and change records.
- Manufacturing processes, engineering concepts, and problem-solving methodologies.
- FDA QSR, ISO 13485, ISO 9001, GMP environments, MDR, and CMDR requirements (preferred).
- Validation activities, laboratory testing, statistical analysis, and risk assessments (preferred).
- Medical device packaging systems, sterile barrier systems, and validation methodologies (preferred).
The Personality Part: - Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)- 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.
