Senior Engineer, Process Engineering and Packaging

AstraZeneca • Gaithersburg, MD

2d • $108,194 - $162,291

About The Position

This position as a Senior Engineer, Process Engineering and Packaging sits within the Process Engineering and Packaging (PEP) department within the Biologic Drug & Combination Product development parent organization (Dosage Form Design and Development, DFDD) in Gaithersburg, MD. The PEP group is staffed with engineers and scientists who develop manufacturing processes such as compounding, aseptic filling, device assembly, and packaging. PEP designs these processes, and tech transfers them to manufacturing sites for clinical products up through licensure. Process development, characterization and validation are core responsibilities of the department.

Requirements

• BS or MS degree in mechanical, chemical, or pharmaceutical engineering, chemistry, materials science, or a related engineering or pharmaceutical science field with 5+ years of experience or a PhD and 0+ years of experience.
• The candidate should have introductory-level knowledge in several of the following areas: Biopharmaceutical / combination drug product development Process validation Fill-finish unit operations such as filtration, mixing, and aseptic filling Experimental design, wet-laboratory work, and data analysis Leadership, communication, technical writing

Nice To Haves

• Prior experience in biologic drug development or manufacturing.
• Knowledge of regulatory guidance (i.e.- biologics, cell and gene therapy, aseptic processing, validation, cGMP, and combination products).

Responsibilities

• Process Design and Development: Design fill/finish manufacturing processes suitable for clinical or commercial-scale production for biologic and novel therapeutic products.
• Evaluate current and new manufacturing technology to drive better quality and operational advantages.
• Develop pilot laboratory capabilities required for biologic and novel therapies.
• Characterize processes to establish acceptable processing conditions.
• Tech Transfer and Validation: Support clinical-stage and commercial technical transfers to internal facilities and contract manufacturers.
• Work within an internal sending unit team including development functions (device, analytical, packaging, formulation, fill and assembly process SMEs), supply chain, project management and QA.

Benefits

• Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees