Participates in internal and external Audits and provides technical expertise for risk assessments and compliance assurance programs.
Ownership of submissions of Packaging Design Documentation to notified bodies.
Assures delivery of robust, cost effective, fully compliant packaging solutions that meet current and evolving customer's needs.
Has full technical responsibility for interpreting, organizing, executing and coordinating assignments.
Leads troubleshooting in the resolution of packaging related issues in manufacturing and the field.
Develops recommendations on general packaging guidelines and standards for processes and functional requirements.
Oversees issue management with technical responsibility to ensure problems are solved in a compliant and effective manner and ensure our organization reaches high levels of efficiency.
Maintains up to date knowledge of the industry and regulatory trends and standards related to packaging and ensures these are translated into working practices.
Knows and follows all laws and policies that apply to one's job, and maintains the highest levels of professionalism, ethics and compliance at all times.
Subject matter expert for packaging department (job function dependent) and is responsible for internal and external audits.
Serve as a mentor for other team members and may supervise direct reports.
Internal cross functional networking and external benchmarking of new technologies, materials, solutions and suppliers.
Evaluates the validation approach and strategy to ensure continuous improvement consistent with established and evolving regulatory and company requirements.
Requirements
Bachelor’s degree in engineering or equivalent Technical Degree or equivalent experience required.
4 – 6 years related experience
Experience in the packaging industry
Experience in packaging qualification or laboratory testing
Experience in a regulated environment
Demonstrated record of successful project management.
Knowledge of ISO13485, ISO11607, ISTA and ASTM is preferred
Application and interpretation of process DOE’s (mini-tab preferred), GR&R, IQ/OQ/PQ, Fishbone, etc. is required
Demonstrated experience working and communicating with internal and external partners, including vendors and suppliers of direct materials and services