We are seeking a Packaging Engineer to join the Process Engineering and Packaging team (PEP). The PEP function develops clinical and commercial fill/finish processes, device/combination product assembly processes, and packaging for biopharmaceutical products in the AstraZeneca Biologics portfolio. Packaging Engineer is to provide packaging support to new product development projects, from clinical trials and new product introductions. This position requires effective collaborative interactions with multiple function groups, both internal/external manufacturing sites and packaging suppliers. Prior experience working with pharmaceutical packaging are essential. This individual must be able to work effectively in a matrix environment and be able to influence internally and externally.
Major Duties and Responsibilities:
- Provide packaging support to drug product development projects.
- Author technical documentation related to packaging design or user requirements, design verification, design/technology transfer, qualification or validation protocols and reports, specifications, technical drawings etc.
- Develop packaging specifications, acceptance testing and validating new packaging materials, equipment and processes.
- Conduct packaging (carton, box…) design, development, risk assessment and qualification.
- Collaborate with packaging suppliers to ensure consistent quality and to verify supplier accountability for specifications.
B.S., or M.S. in Package Engineering, Packaging Science, Mechanical Engineering, Materials Science, or other relevant scientific or engineering field.Experience:Associate Scientist II:
Bachelor's degree and 8+ years OR Master's degree and 5+ years of experience.Scientist I:
Bachelor's degree and 10+ years' experience OR Master's degree and 8+ years' experience OR PhD and 0+ years' experience.Requirements:
- Demonstrated ability to working in collaborative team environment across multiple technical functions.
- Working knowlege of drug product packaging design and validation meeting both technical requirements as well as regulatory expectations.
- Prior experience in drug product shipping qualification (e.g. vials, prefilled syringes and autoinjectors)
- Working knowledge of testing methodologies and test standards including shock, drop and vibration tests, peel force test, barrier analysis, container closure integrity, DIN, ISO, ISTA, ASTM, USP, FDA, and EMA standards for packaging design and validation.
- Knowledge of packaging equipment and process related to drug product packaging activities and labeling systems.
- Strong analytical, technical writing, verbal communication and interpersonal skills.