Packaging Engineer - Process Validation Lead

ATR International; Connecticut; On-site; USD 85,000 - 120,000; Full time

Job summary

ATR International seeks a packaging validation specialist to qualify materials for absorbable sutures. You will lead process development and validation planning, communicating milestones to engineering management.

The role requires a BS in Engineering with 3–5 years of related experience, IQ/OQ/PQ expertise, and familiarity with DOE (Minitab). Onsite in New Haven, CT with cross-functional collaboration across GMP environments.

Qualifications

• Requires a University Degree (BS) in Engineering with 3-5 years of related experience.
• Experience in IQ/OQ/PQ and process validation lifecycle.
• Knowledge of medical device regulatory standards is a plus.
• Familiar with DOE (Minitab) preferred.
• Experience documenting validation and change control.

Responsibilities

• Validate and qualify new packaging materials for absorbable suture products.
• Lead process development activities and create validation plans.
• Communicate project deliverables and timing to engineering management.
• Design, develop, test containers considering moisture, chemicals, temperature, light, and tampering.
• Support GMP documentation and prototype line development in manufacturing facilities.
• May mentor entry level professionals and others in the team.

Skills

Packaging experience

Validation experience

DOE (Minitab)

Office software

Education

BS Engineering

Tools

Cognex Vision Systems

Keyence Vision Systems

Job description

ATR International seeks a packaging validation specialist to qualify materials for absorbable sutures. You will lead process development and validation planning, communicating milestones to engineering management.

The role requires a BS in Engineering with 3–5 years of related experience, IQ/OQ/PQ expertise, and familiarity with DOE (Minitab). Onsite in New Haven, CT with cross-functional collaboration across GMP environments.