Senior Packaging Engineer – Non‑Sterile (US & WW)

solique ag; Warsaw (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Medartis is seeking a Manufacturing Engineer to design, set up, qualify, and operate a non-sterile packaging room in Warsaw, IN. You will lead packaging environment establishment, cleaning validations, and US packaging projects while ensuring compliance with FDA QSR/21 CFR 820 and ISO 13485.

The role requires hands-on problem solving, cross-functional collaboration, and the ability to represent Medartis as an SME during audits; travel may be required.

Qualifications

• Bachelor's degree in engineering (Mechanical, Manufacturing, Industrial, Packaging, Biomedical) or related field.
• At least 5 years of manufacturing engineering experience.
• Minimum 3 years in a medical device company.
• Experience setting up and executing cleaning validations.
• Experience executing non-sterile packaging projects in the U.S.
• Experience setting up a packaging room, cleanroom, or controlled manufacturing area.
• Knowledge of validation protocols (IQ/OQ/PQ) and related reports.

Responsibilities

• Lead design, layout, and setup of a new non-sterile packaging room.
• Develop and document cleaning validations for packaging area and equipment.
• Plan packaging projects for the U.S. market and support WW projects.
• Establish and qualify packaging processes and equipment; support process validations.
• Create and maintain technical documentation (WIs, procedures, reports).
• Troubleshoot complex packaging-related issues and drive improvements.
• Lead on-the-job training of packaging operators.

Skills

Problem-solving

Prioritization

Cross-functional teamwork

Documentation

Auditing support

Education

Bachelor's degree in engineering (Mechanical, Manufacturing, Industrial, Packaging, Biomedical)

Tools

IQ/OQ/PQ

Job description

Medartis is seeking a Manufacturing Engineer to design, set up, qualify, and operate a non-sterile packaging room in Warsaw, IN. You will lead packaging environment establishment, cleaning validations, and US packaging projects while ensuring compliance with FDA QSR/21 CFR 820 and ISO 13485.

The role requires hands-on problem solving, cross-functional collaboration, and the ability to represent Medartis as an SME during audits; travel may be required.