Packaging Engineer II

Real; North Haven (CT); On-site; USD 75,000 - 105,000; Full time

Job summary

Specialist Staffing Group is seeking a Packaging Engineer II in North Haven, CT to lead validation and qualification of new packaging materials for absorbable suture products. This role focuses on process development and creating validation plans in line with industry standards, serving as project lead and coordinating timelines with engineering management.

You will design, test, and specify packaging containers and exteriors to protect products, considering moisture, temperature, and handling.

Qualifications

• Bachelor's degree in engineering and 3–5 years of relevant experience.
• Experience in packaging validation lifecycle (IQ/OQ/PQ).
• Familiarity with GMPs and medical device change control.

Responsibilities

• Lead validation and qualification of new packaging materials.
• Develop packaging process development plans and test containers.
• Define packaging specs based on product and cost constraints.
• Coordinate GMPs and support prototype line development.

Skills

Packaging Experience

Validation Experience - Process Dev

OQ

IQ

PQ

Familiarity with Cognex

Keyence vision inspection systems

Education

Bachelor's degree in engineering (Mechanical/Manufacturing/Packaging)

Tools

Cognex vision systems

Keyence vision inspection systems

DOE (Minitab)

CSV validation

SOP Development

Change control of medical devices

Job description

A Packaging Engineer II is sought to lead the validation and qualification of new packaging materials for absorbable suture products. The role focuses on process development and the creation of validation plans in compliance with industry standards. The engineer will serve as project lead, communicating deliverables and timelines to engineering management and supporting the GST Focus Factory product line, specifically validating and qualifying new nylon film.

Key responsibilities include designing, developing, and testing containers to ensure product protection, display, and handling. The engineer will determine packaging specifications based on product requirements, cost constraints, legal standards, and protection needs against variables such as moisture, chemicals, temperature, and handling. Additionally, the role involves designing package exteriors with consideration for product identification, sales appeal, aesthetic quality, and production techniques. Documentation management, coordination of Good Manufacturing Practices (GMPs), and support for prototype line development in manufacturing facilities may also be required.

Candidates must have a bachelor's degree or higher in engineering (mechanical, manufacturing, or packaging) and 3-5 years of relevant experience. Essential technical skills include packaging experience, process validation (IQ, OQ, PQ), and familiarity with Cognex and Keyence vision inspection systems. Experience with process validation lifecycle, DOE (with Minitab), computer and software validation (CSV), SOP development, and change control of medical devices is preferred.

The role is full-time and requires onsite presence. The successful candidate will work independently on moderately complex projects, set objectives for their area, and contribute to project milestones. Strong communication skills and the ability to provide guidance to junior colleagues are important.

Must-Have Skills

• Packaging Experience
• Validation Experience - Process Development
• OQ
• IQ
• PQ
• Familiarity with Cognex
• Keyence based vision inspection systems

Nice-to-Have Skills

• Computer
• software validation CSV
• SOP Development
• Change control of Medical Devices

EOE Statement

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.