Packaging Validation Engineer

EQVAL Group, Inc.

is a company that provides services to the manufacturing industry ( Medical Devices, Pharmaceuticals, Biotechnologies, others ).

We work with an extraordinary group of professionals ( employees and contractors ) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.

The Packaging Validation Engineer  to support a Medical Device manufacturing facility in Añasco, PR.

The ideal candidate will bring strong experience in packaging validation, process validation, and documentation within regulated medical device environments.

Key Responsibilities : Support data gathering and compilation of required documentation for packaging validations.

Generate technical documents including Change Controls, Validation Protocols (IQ, OQ, PQ), Drawings, Routers, etc.

Execute validation activities including : Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Shipping & Shelf-life studies (aging) Test Method Validation (TMV) Perform integrity and strength tests such as : Peel, burst, creep, bubble leak, dye penetration Ensure all validation efforts comply with ISO 11607 .

Use statistical tools (Minitab or similar) for data analysis and reporting.

Work cross-functionally to ensure timely delivery of project milestones.

Maintain compliance with FDA, GMP, ISO, OSHA, and EPA standards.

Required Qualifications : Bachelor’s Degree in Engineering (Mechanical, Industrial, Electrical, Chemical, Biomedical) or Science.

Minimum of 5–7 years of experience in medical device or pharmaceutical manufacturing.

At least 5 years in process, quality, or validation engineering roles.

Hands-on experience in packaging validation and ISO 11607 compliance.

Strong understanding of packaging materials, test methods, sealing processes, and transit testing.

Experience with remediation or compliance projects.

Proficiency with electronic PLM systems and technical documentation.

Skilled in statistical analysis tools such as Minitab .

Fully bilingual in English and Spanish .

Willingness to work extended hours or weekends as needed.

Strong communication, analytical, and problem-solving skills Benefits : Dental insurance Employee assistance program Employee discount Health insurance Life insurance Paid time off Professional development assistance Vision insurance Schedule : 8 hour shift Work Location : In person On-site role – Applicants must currently reside in Puerto Rico Powered by JazzHR