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Engineering Project Manager

4 months ago

Gaithersburg, United States Ampcus Full time
Principal Engineer - Packaging Design

Location: Gaithersburg, but will consider candidates who can work Hybrid opportunity with up to 2 days a week remote

Contract to hire based on business needs and performance.

Schedule: Regular business hours

Up to 15% travel

Are you ready to make a significant impact on patients' lives? As a Principal Engineer of Packaging Design, you will be responsible for the planning, design & development, qualification and transfer of packaging materials (secondary and tertiary), as well as all aspects of their manufacture and use in the manufacture, storage, and transport of the final drug product throughout its lifecycle.

Your role will involve leading the packaging group within biologics GTO to achieve best in class, optimized packaging. You will also plan, design & develop, qualify, transfer and support the manufacturing of packaged products in accordance with business needs and laws/regulations throughout a product's lifecycle.

Essential Skills/Experience:
• Bachelor's degree in engineering or related field.
• Minimum of 10 years of significant engineering or operational experience.
• Excellent problem-solving abilities.
• Strong interpersonal, organizational, collaboration and communication skills.
• Demonstrated ability to progress a packaging project from inception to commercialization including packaging materials, designs and manufacturing processes, qualification, validation and systems.
• Experience designing packages with auto-CAD for secondary packaging systems for vials and combination products (accessorized pre-filled syringes, auto-injectors), and tertiary systems.
• Experience in designing shipping qualification studies (real and simulated with accelerometers).
• Experience in transferring and supporting assembly, label and pack production.
• Knowledge of current Good Manufacturing Practices (cGMPs), packaging laws, regulations, and guidance, and experience authoring quality management system (QMS) documents: change controls, CAPAs (Corrective Actions / Preventive Actions) and deviations.
• Authoring study protocols and reports, specifications, SOPs, batch records, etc.

Desirable Skills/Experience:
• Experience in product serialization for tracking and traceability.