Packaging Engineer - Technology Transfer

Responsibilities 

Area of responsibility 1: [Lead and support packaging process, labeling and component improvement]

Main activities 

• Develop and maintain packaging and component databases.
• Support risk assessments with key cross functional stakeholders and set up the control strategy.
• Determines and coordinates physical testing to ensure product and package integrity for manufacturing through end users.
• Participate in core team meetings and ensure collaboration with cross-functional stakeholders.
• Develop and execute engineering studies to qualify packaging components, processes and equipment.
• Basic ability to modify existing packages by taking them from the bench, pilot plant and commercial scale based on customer or consumer needs. 
• Ability to create packaging material specifications providing technical information necessary to support the product/packaging configurations; to ensure projects deliver at efficient cost, line performance, package quality, supply chain requirements, and consumer satisfaction.
• Develop and maintain the packaging processes, systems, procedures, test methods, and component 
• specifications required to assure compliance with all packaging-related requirements.
• Manage multiple projects and be able to focus and prioritize on important projects.

Expected results: Ensure robust, efficient, and compliant packaging components, labeling and processes

Area of responsibility 2: [Lead packaging engineering studies to introduce new and improved packaging materials, techniques and/or technologies]

Main activities 

• Create scale up models by developing expert processing equipment understanding and characterization at different scales.
• Evaluate packaging and components to support cost savings and change initiatives. 
• Provides technical leadership of equipment, automation and/or facility improvement projects
• Utilize technical packaging knowledge to support root cause problem solving. Provide solutions based on risk and benefit assessments using basic problem analysis and resolution, statistical methods, and design of experiments tools.
• Prepares engineering evaluations and test plans for and executes modification change control documentation.

Expected results: Packaging process, material and equipment understanding, control, and capability

Area of responsibility 3: [Develop packaging engineering documentation and support GMP manufacturing]

Main activities 

• Author and review GMP-critical documentation, such as experimental reports, batch records, process work instructions, development and technology transfer reports.
• Support GMP product and process investigations including deviations, change controls and CAPAs.
• Complete manufacturing process reviews of processes intended for technology transfer, highlighting critical process parameters and critical material attributes.
• Write and/or review CMC regulatory documents.

Expected results: Guarantee proper documentation for training and compliance requirements

Profile

Requirements (Diploma and experience)

• Bachelor’s degree (or equivalent) in a science or engineering discipline
• Requires 3-5 years of experience in packaging engineering or packaging process development. At least 2 years in a Pharmaceutical / FDA regulated environment
• Working knowledge of cGMP standards and experience working in a regulated environment

Skills

• Proven analytical thinking and problem-solving skills
• Demonstrated success operating in cross-functional teams
• Strong verbal, written and interpersonal communication skills
• Strong organizational and computer skills
• Prior experience using lean and six sigma principles and tools.
• Ability to travel up to 10% of time