Associate Director, Associate Director, Packaging Component Engineering

Job Description

We aspire to be the premier research-intensive biopharmaceutical company. At our company, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. 

We are seeking an Associate Director for our Packaging Component Engineering team within Packaging Technology Operations (PTO) at our Wilson, NC human health packaging site who will play a pivotal role in our mission to save and improve lives around the world. This position serves as the primary leadership position overseeing all personnel and leadership support within this area.

The Associate Director of Packaging Component Engineering will be responsible for supporting packaging and component engineering capabilities for the Wilson site focused on effective component life cycle management, related quality investigations, lines projects, and packaging continuous improvement projects. Responsible for process performance support and troubleshooting products packaged at our Wilson location and working closely with other site and above-site groups for the introduction of new products, network transfers and processes as well as external suppliers, packaging commercialization, and global support functions.

This position will report to the Director of Packaging Technology Operations and will have frequent interaction with other business units at the site as well as external suppliers, packaging commercialization, and global support functions.  The team will also support other engineering activities at the site as well as quality risk management.

Primary Responsibilities

• Lead the packaging component engineering function in supporting Wilson site operations, new product introductions, technology transfers, and long-term technical readiness.

• Set direction for packaging component strategy, supplier technical oversight, and cross-functional execution across site and global teams.

• Drive strategic platform standards for packaging images resulting from new critical technologies introduction and/or marketing requirements

• Guide design transfer, new component development, vendor qualification, and product launch readiness.

• Author, review and approve component specifications, technical assessments, validation packages, and supplemental regulatory documentation.

• Establish priorities to improve packaging productivity, component robustness, and lifecycle management.

• Oversee quality, regulatory, and compliance activities, including investigations, inspections, technical documentation, and change control as related to packaging systems.

• Direct troubleshooting and resolution of packaging line and component-related issues to ensure reliable manufacturing performance.

• Lead root cause investigations, corrective/preventive action plans, product impact assessments, and supplier/customer complaint resolution.

• Provide component engineering support for capital projects, including the evaluation of packaging technologies and the execution of equipment design reviews, purchase specifications, FATs, and IQ/OQ/PQ.

• Own component-related change management, impact assessments, and workflow governance using relevant systems and tools.

• Partner with Procurement, Supplier Management, Manufacturing, Quality, and Global Technical Operations to ensure supplier performance and technical alignment for common packaging platforms.

• Build, mentor, and develop a high-performing team of engineers to support business and site objectives.

• Promote a culture of safety, quality, regulatory compliance, accountability, and continuous improvement across the organization.

Education Requirements

• Bachelor’s degree in science (Packaging Science/Engineering preferred) and a minimum ten years of experience in packaging operations, pharmaceutical unit operations, or process design OR a Master’s degree in science or equivalent and a minimum eight years of experience OR a Ph.D. and a minimum five years of experience

Experience and Skills

Required

• Comprehensive background in packaging process and components

• Experience working in GMP environment

• Demonstrated leadership and teamwork skills

• Effective analytical and decision-making ability

• Effective written and verbal communication ability

• Knowledge of formal problem-solving techniques such as root cause analysis and Lean Six Sigma.

• Technical writing and document review experience (deviations, change requests, standard operating procedures, protocols, etc.).

Preferred