QUALIFICATIONS:

• Bachelor’s degree in Engineering, Packaging Science, or related field.
• 4+ years of experience in packaging validation or packaging engineering, preferably in the medical device and/or pharmaceutical industry.
• Must be available to perform duties On site in Jayuya, PR
• Experience with validation documentation and protocols (IQ/OQ/PQ).
• Familiarity with regulatory requirements
• Strong analytical, organizational, and communication skills.
• Proficient in technical writing and data analysis.

PREFERRED QUALIFICATIONS:

• Strong Validations experience with packaging equipment or equipment qualification

ROLE SUMMARY:

The Packaging Validation Engineer is responsible for ensuring that packaging systems for medical devices comply with applicable regulations, standards, and internal requirements. This includes the development, validation, and verification of packaging processes and materials to ensure product integrity, sterility, and usability throughout the product lifecycle.

KEY RESPONSIBILITIES:

• Develop and execute packaging validation protocols (IQ, OQ, PQ) in accordance with r regulatory requirements.
• Document and report validation activities, deviations, and results in accordance with Good Documentation Practices (GDP).
• Support root cause investigations, CAPAs, and change control processes related to packaging.
• Maintain up-to-date knowledge of packaging materials, standards, and regulatory guidelines.
• Assist in audits and inspections related to packaging validation.