We are seeking a Senior Packaging Engineer to drive complex packaging solutions across our manufacturing network. You will be the technical expert responsible for launching new drug products, optimizing packaging operations, and ensuring global compliance.
Key Responsibilities
- Launch & Tech Transfer Leadership: Lead packaging project execution for New Product Introductions and Technology Transfers, focusing on Oral Solid Dose (OSD) and advanced Combination Devices/Kits.
- CMO Management & Operations: Provide expert technical and operational oversight for global Contract Manufacturing Partner (CMO) packaging sites, with a focus on operations within the EMEA region.
- Packaging Optimization: Drive Cost Efficiency and Continuous Improvement initiatives across sites and CMOs, meeting near- and long-term savings targets.
- Compliance & Documentation: Manage all GMP documentation, including change controls, packaging specifications, technical reports, and lifecycle management workflows. Ensure adherence to cGMP and major regulatory requirements.
- Design & Testing: Design and execute package testing and transportation studies for diverse formats, including bottles, vials (cold chain), and combination products.
- Device & Kitting: Engineer innovative, patient-centric, and cost-competitive secondary packaging solutions for device assembly and kitting projects. Represent MPLBO as the specialist on Device Teams.
- Project Governance: Manage projects following global guidelines, utilizing change control systems and project governance policies throughout the full lifecycle.
- Serialization: Apply basic knowledge of global Serialization and Aggregation requirements (e.g., EU FMD, DSCSA) to relevant projects.
Requirements
- Experience: Extensive experience in the Pharmaceutical, Biotech, or related industry is essential.
- Education: Degree in Packaging, Device, Quality Engineering, or a related field.
- Technical Expertise: Strong technical knowledge of OSD, parenteral, and/or device packaging solutions, materials, processes, qualification, and validation in a high-volume manufacturing setting.
- Operational Skills: Proven experience with primary/secondary packaging processes, device/kitting assembly, transportation studies, and qualification/validation.
- Essential Skills: Demonstrated expertise in CMO Management (EU experience required), Project Management, and Stakeholder Management.
- Soft Skills: Exceptional written, verbal, and interpersonal communication skills with a proven ability to collaborate with cross-functional internal and external teams (Quality, Regulatory, Supply Chain, etc.).
