Principal Engineer
Posted on :
24-11-2024
Employer Active
1 Vacancy
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Job Description
- Accountabilities:
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 14 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, reports, specifications, SOPs, batch records, etc.
- Ability to travel to AZ site locations as needed. up to 20%
- Desirable Skills/Experience:
- Experience in product serialization for tracking and traceability.
Employment Type
Full-time
Department / Functional Area
Key Skills
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