Packaging Engineer II: Validation & Innovation

Lancesoft; North Haven (CT); On-site; USD 85,000 - 110,000; Full time

Job summary

Lancesoft in North Haven, CT is seeking an engineer to validate and qualify packaging materials for absorbable suture products, leading projects and coordinating with engineering management.

You will develop validation plans, design containers, ensure GMP compliance, and support prototype line development in manufacturing facilities. A Bachelor's degree in engineering and 3–5 years in medical devices are preferred.

Qualifications

• Experience in equipment IQ, OQ and PQ and/or process validation.
• Understanding of Process Validation Lifecycle from process characterization to performance qualification.
• Preferred experience in DOE with Minitab.
• Experience with CSV, SOP development, and change control of medical devices.

Responsibilities

• Validate and qualify new packaging materials (foil, Tyvek, and film) for absorbable sutures.
• Develop validation plans and processes in compliance with company standards.
• Lead projects and communicate deliverables and timelines to engineering management.
• Design, develop, and test containers for product protection, display, and handling.
• Determine packaging specifications considering cost, regulatory requirements, and protection needs.
• Document management and coordination of GMPs.
• Support prototype line development in manufacturing facilities.

Skills

IQ/OQ/PQ qualification

Process validation lifecycle

DOE with Minitab

CSV validation

SOP development

Change control

Education

Bachelor's degree in Engineering/Mechanical/Manufacturing/Packaging

Tools

Minitab

Job description

Lancesoft in North Haven, CT is seeking an engineer to validate and qualify packaging materials for absorbable suture products, leading projects and coordinating with engineering management.

You will develop validation plans, design containers, ensure GMP compliance, and support prototype line development in manufacturing facilities. A Bachelor's degree in engineering and 3–5 years in medical devices are preferred.