Packaging Development Engineer Position Available In Wilson, North Carolina

Job Title:

Packaging Development Engineer Job Description This role is responsible for independently initiating, executing, and implementing advanced packaging designs for drug products on large-scale projects. The engineer applies complex principles of packaging technology with minimal supervision and collaborates with cross-functional teams to ensure project success in terms of cost, schedule, and performance. The position may also involve supervising packaging engineering activities for special projects. Responsibilities Represent the Packaging Development department on new product development teams. Prepare CMC documentation for NDA and ANDA submissions and review peer documents for regulatory compliance. Lead high-profile packaging projects that impact manufacturing, marketing, sales, and profitability. Independently develop and implement packaging material specifications (MCSs), BOMs, CNs, packaging descriptions, and bar code assignments. Coordinate and communicate project details with Product Development, Marketing, Manufacturing, Materials Management, Quality Assurance, and Purchasing. Conduct cost-reduction studies to improve efficiency, reduce waste, and lower labor requirements. Ensure all packaging designs and materials meet legal, technical, and FDA requirements. Provide necessary data and specifications to Regulatory Affairs for new product submissions. Manage multiple projects simultaneously, demonstrating adaptability and resilience under pressure. Additional tasks and projects as assigned. Essential Skills Bachelor’s degree in engineering (Packaging or Mechanical Engineering preferred). 5-10 years of engineering experience, including familiarity with FDA regulations and medical, drug, or device products. Experience in the pharmaceutical or medical diagnostics industry. Proficiency in container closure systems such as vial/stopper/seal, SVP and LVP prefilled bags, and prefilled syringes. Strong technical knowledge in materials, equipment, design, and specification writing. Excellent technical writing, verbal communication, and negotiation skills. Proficiency in software tools including word processing, spreadsheets, databases, project management, and presentation software. Strong judgment, decision-making, problem-solving, and multitasking abilities. Capable of working independently and adapting to change. Additional Skills & Qualifications Certified Packaging Engineer preferred but not required. Work Environment The work environment is dynamic and collaborative, involving cross-functional teams and diverse technologies. The role requires adaptability and resilience under pressure, with a focus on regulatory compliance and innovation in packaging designs.