Position SummaryThe
Senior Engineer to support packaging engineering activities within a pharmaceutical/biotechnology manufacturing environment. This role is responsible for leading packaging development, material evaluations, technical investigations, validation activities, and continuous improvement initiatives to ensure product quality, compliance, and supply chain integrity. The ideal candidate will possess strong expertise in packaging systems, material science, engineering documentation, and regulatory requirements applicable to healthcare products.
Key Responsibilities- Lead packaging engineering projects supporting commercial and new product introduction initiatives.
- Evaluate, select, and qualify primary and secondary packaging components to meet product protection, compliance, and business requirements.
- Develop, revise, and approve engineering drawings and packaging specifications using CAD and design software.
- Provide technical oversight for packaging materials including labels, trays, lidding materials, leaflets, paperboard, sterile barrier systems, corrugate packaging, and related structural components.
- Design, execute, and evaluate packaging studies, tests, and validations in support of product lifecycle management.
- Author and review technical protocols, test reports, engineering assessments, and supporting documentation.
- Writing test protocols, performing technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components.
- Perform material characterization, technical evaluations, and testing to support packaging component selection and qualification.
- Partner with Quality, Manufacturing, Supply Chain, Validation, and Regulatory Affairs teams to ensure project success and compliance.
- Support continuous improvement initiatives focused on packaging performance, cost optimization, sustainability, and operational efficiency.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and applicable regulatory requirements.
Minimum Qualifications• Doctorate degree in Engineering; OR
• Master's degree in Engineering and 2 years of engineering experience; OR
• Bachelor's degree in Engineering and 4 years of engineering experience.
• Educational background in
Mechanical Engineering preferred.
• Fully bilingual (English and Spanish).
• Familiarity with distribution and transit testing standards, including:
- ASTM D4169
- International Organization for Standardization (ISO) standards
- Technical Association of the Pulp and Paper Industry (TAPPI) standards
- United States Pharmacopeia (USP)
- European Pharmacopeia (EP)
Preferred Qualifications• Packaging Engineering and/or Materials Science experience.
•
7+ years of final product manufacturing experience.
•
4+ years of experience within the
Pharmaceutical and/or Biotechnology industry.
• Strong understanding of
packaging materials and structural components used in healthcare products.
• Experience with
engineering design software such as AutoCAD, SolidWorks, Adobe Illustrator, or equivalent.
• Knowledge of packaging distribution testing standards and industry regulations.
