Product Launch & Lifecycle Engineer IV - Peptide​/DS

The Product Launch & Lifecycle Engineer will manage cross-functional project teams to support product launch, lifecycle, and technical transfer objectives of Human Pharma US Supply. This role will ensure availability of Boehringer Ingelheim products at product launch and throughout lifecycle between Boehringer sites and/or to external contract manufacturing organizations (CMO), including supporting process and packaging development and registration, start-up of commercial production, and transfer to lifecycle support.

The Product Launch & Lifecycle Engineer will troubleshoot and resolve obstacles during process and packaging development, transfer, validation, and commercialization. The incumbent will provide lifecycle support (process and packaging expertise) for human pharma/animal health/BIO products produced in the US or imported for the US market. The job scope for this role includes aspects of both process and packaging engineering. Work assignments may be allocated between these disciplines based on skills and experience.

The role is based on-site at our Columbus, OH location with hybrid flexibility of 2-3 days per week on-site.

• Ensures availability of Boehringer Ingelheim products throughout lifecycle and provides lifecycle support (process and packaging expertise) for human pharma/animal health/BIO products produced in the US or imported for the US market.
• Manages and supports cross-functional teams to implement product lifecycle changes (material and component suppliers, site changes, specifications, etc.) to ensure continued market supply.
• Manages Continued Process Verification, Control Strategy Summary, and Transport Qualification processes for assigned commercial products, monitoring product performance.
• Coordinates continuous improvement activities for launched products through initial commercial production phase through lifecycle.
• Supports Third Party Quality and Commercial Quality by providing technical and operational expertise in evaluating events, deviations, and complaint investigations affecting US marketed products.
• Identifies product quality, process, and packaging robustness optimization opportunities through analysis of product performance and collaboration with peer and customer groups.
• Collaborates with organizational partners to support these initiatives, as necessary.
• Collaborates with Regulatory Affairs to support assessment of the regulatory impact of potential product changes, documentation of implemented changes, and ensure regulatory compliance.
• Prepares and/or reviews line trial/validation protocols and reports, master batch records, product or packaging material specifications, master data, master packaging specifications, defines technical elements for product labeling, and completes other documents for assigned products and projects to meet established project timelines.
• Collaborates with development partners/customers (e.g., Boehringer sites, External CMOs) for the process and packaging development and registration of new product market authorizations ensuring all project timelines are met.
• Collaborates with development partners during process and packaging development to ensure knowledge transfer to commercial operations.
• Provides critical review of new products, processes, and packaging regarding fit with US operational capabilities.
• Provides feedback to development partners on potential critical mismatches between new products, processes, and packaging and operational capabilities, identifying potential optimization opportunities.
• Identifies and recommends selection and/or design of processes and systems which meet product and regulatory requirements, are compatible with BI production practices, and meet marketing and financial needs.
• Executes assigned project deliverables with minimal guidance from functional management and/or senior engineers; may require guidance on technical aspects of medium to high complexity, as well as problem solving approaches for dealing with project roadblocks (technical and/or logistic).

• Active Pharmaceutical Ingredient (API) & Peptide Manufacturing
• Deep technical understanding of…