Packaging Engineering Lead - Non-Sterile Medical Devices

Medartis Inc. - United States; Warsaw (IN); On-site; USD 85,000 - 105,000; Full time

Job summary

Medartis Inc. in Warsaw, Indiana seeks a Manufacturing Engineer to design, set up, validate, and operate a non-sterile packaging room in compliance with FDA QSR/21 CFR 820 and ISO 13485.

You will act as SME for current and future packaging operations, driving projects from concept through validated production. You will lead IQ/OQ/PQ validations, establish packaging processes, author procedures and BOMs, and collaborate across Quality, Operations, and Procurement to deliver robust, compliant

Qualifications

• Bachelor's degree in engineering (Mechanical, Manufacturing, Industrial, Packaging, Biomedical) or related field.
• At least 5 years manufacturing engineering experience; minimum 3 years in medical devices.
• Experience setting up packaging room, cleanroom or controlled manufacturing areas.
• Experience with IQ/OQ/PQ validation protocols and project execution.
• Working knowledge of FDA QSR/21 CFR 820 and ISO 13485.

Responsibilities

• Lead the design, layout, and setup of a new non-sterile packaging room, including equipment selection and process flow.
• Develop, execute, and document cleaning validations for packaging area, equipment, and processes.
• Plan and execute non-sterile packaging projects for the U.S. market; support WW packaging projects as needed.
• Establish and qualify packaging processes and equipment (IQ/OQ/PQ) and support process validations.
• Author, maintain, and improve technical documentation such as work instructions, procedures, and routers.

Skills

Project management

Problem solving

Cross-functional collaboration

Regulatory understanding

Documentation

Education

Bachelor's degree in engineering

Tools

IQ/OQ/PQ validation

MRP systems

Cleanroom setup

Job description

Medartis Inc. in Warsaw, Indiana seeks a Manufacturing Engineer to design, set up, validate, and operate a non-sterile packaging room in compliance with FDA QSR/21 CFR 820 and ISO 13485.

You will act as SME for current and future packaging operations, driving projects from concept through validated production. You will lead IQ/OQ/PQ validations, establish packaging processes, author procedures and BOMs, and collaborate across Quality, Operations, and Procurement to deliver robust, compliant