Packaging Engineer II

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

Job summary

Specialist Staffing Group is seeking a Packaging Engineer II to lead the validation and qualification of new packaging materials for absorbable suture products. The role focuses on process development and creating validation plans in compliance with industry standards, acting as project lead to communicate deliverables and timelines to engineering management.

Responsibilities include designing containers, determining packaging specs, and coordinating GMPs, with onsite presence required.

Qualifications

• Bachelor’s degree or higher in engineering (mechanical, manufacturing, or packaging).
• 3-5 years of relevant experience in packaging or medical devices.
• Experience with process validation lifecycle (IQ/OQ/PQ).
• Familiarity with Cognex vision systems.
• Familiarity with Keyence vision inspection systems.
• Experience with SOP development and change control is preferred.

Responsibilities

• Lead validation and qualification of new packaging materials for absorbable suture products.
• Design, develop, and test containers to ensure product protection and handling.
• Determine packaging specifications based on product requirements, cost, and legal standards.
• Design package exteriors with product identification, sales appeal, and production considerations.
• Manage documentation, GMP coordination, and prototype support in manufacturing facilities.
• Provide guidance to junior colleagues and communicate deliverables and timelines.

Skills

Packaging Experience

Validation Experience - Process Dev

IQ

OQ

PQ

Cognex familiarity

Keyence vision systems familiarity

Education

Bachelor's degree in engineering (mechanical, manufacturing, or packaging)

3-5 years of relevant experience

Tools

Cognex

Keyence

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.