Packaging Engineer II

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.

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