Position SummaryWe are seeking a highly motivated Sr. Engineer to provide technical leadership and engineering support for packaging systems and final product manufacturing operations within a regulated pharmaceutical/biotechnology environment. The selected candidate will be responsible for evaluating, qualifying, and supporting primary and secondary packaging materials and components, ensuring compliance with quality, regulatory, and operational requirements. This role requires strong technical expertise in packaging engineering, testing methodologies, project management, and GMP-regulated manufacturing processes.
Key Responsibilities- Provide engineering support for packaging components, systems, and processes used in final product manufacturing operations.
- General packaging and engineering experience supporting final product manufacturing operations within the Pharmaceutical or Biotechnology industry.
- Lead technical evaluations and studies to support the selection, qualification, implementation, and lifecycle management of packaging materials.
- Develop, execute, and approve engineering protocols, test plans, and technical reports to demonstrate packaging system performance and compliance.
- Support packaging validation and qualification activities, including transportation and distribution testing.
- Evaluate packaging materials and components to ensure compatibility, functionality, product protection, and regulatory compliance.
- Analyze test data and generate recommendations to support technical decisions and continuous improvement initiatives.
- In-depth knowledge of pharmaceutical primary and secondary packaging materials and components, including: Bottles, Labels, Trays, Lidding materials, Leaflets, Paperboard packaging, Sterile barrier packaging systems and Corrugated shipping materials.
- Strong technical writing skills, including protocol development, testing documentation, technical evaluations, and final reports.
- Collaborate with Quality, Manufacturing, Supply Chain, Regulatory Affairs, and external suppliers to resolve packaging-related issues.
- Investigate technical deviations, non-conformances, and packaging failures, implementing effective corrective and preventive actions when required.
- Ensure compliance with GMP, GDP, corporate procedures, and applicable industry standards.
- Manage multiple projects simultaneously while maintaining timelines, quality expectations, and business objectives.
- Support change control activities related to packaging materials, components, equipment, and processes.
- Participate in risk assessments and technical reviews to ensure packaging robustness throughout the product lifecycle.
- Familiarity with ASTM D4169 and related ASTM, ISO, TAPPI, USP, and EP testing standards.
Qualifications- Doctorate degree in Engineering, OR
- Master's degree in Engineering and two (2) years of engineering experience, OR
- Bachelor's degree in Engineering and four (4) years of engineering experience.
