Package Testing Engineer II

Summary Of Objective

The Package Testing Engineer II supports PCI’s mission to provide the industry leading experience to clients, developing and commercializing solutions to optimize the delivery of lifesaving medicines and support better health outcomes for patients around the world.

Essential Duties and Responsibilities

• Captures the plans and implementation of packaging designs to meet regulatory/industry guidelines within the package development process.
• Leads and manages package testing projects with internal/external laboratories.
• Works closely in collaboration with functional teams and stakeholders; package designers, process/tooling engineers, project management, purchasing, sales and others to support the successful commercialization of new packaging systems and improvements to existing packaging formats.
• Performs quoting of Testing Services opportunities and maintains metrics tracking.
• Performs sample preparation and package performance feasibility studies in on-site prototyping and testing laboratory.
• Provides packaging engineering consultation services to PCI clients.
• Analyzes/interprets test results and executes root cause analysis as necessary.
• Maintains and tracks digital assets related to packaging design, testing standards and regulations.
• Regularly provides direction and mentorship to in-house interns and other Testing Engineers.
• Supporting internal corporate and marketing activities as needed.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position.
• Performs other duties as assigned by management.

Qualifications

• Bachelor's degree in Packaging Engineering and/or related discipline with 2+ years related industry experience and/or training.
• Knowledge of packaging development process within life sciences industry – preferably pharmaceutical and biotech.
• Good understanding of Formative/Summative Human Factors Validation testing and Child Resistance/Adult Friendly packaging qualifications ISO/EN, CPSC and ASTM.
• Highly collaborative and effective in a cross-functional and fast-paced environment.
• Advanced technical writing and written/oral communication skills.
• Self-driven and innovative mindset.
• Understanding of cGMP and GLP processes/standards (21 CFR Part 211).
• Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
• Basic Mathematical Skills.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
• High Standard of Report Writing.