Product Launch & Lifecycle Engineer III/IV - Aseptic Processing / Sterile Manufacturing

Manages Continued Process Verification (CPV), Control Strategy Summary (CSS), and Transport Qualification processes for assigned commercial products, to monitor product performance.

Coordinates continuous improvement activities for launched products through initial commercial production phase through lifecycle.

Supports Third Party Quality (3PQM) and Commercial Quality by providing technical and operational expertise in evaluation of 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/reports, master batch records, product or packaging material specifications, GBS master data, master packaging specifications, defines technical elements for product labeling, and completes other documents for assigned products/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 that 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/packaging regarding fit with US operational capabilities.

Provides feedback to development partners on potential critical mismatches between new products/processes/packages and operational capabilities and identify potential optimization opportunities.

Identifies and recommends selection and/or design of processes and systems which meet product and regulatory requirements, and are compatible with BI production practices, while meeting marketing and financial needs. May require assistance from functional management to influence development partners in the selection of processes and packaging systems.

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).

Aseptic Processing & Sterile Manufacturing • Provide technical leadership for aseptic processing and sterile manufacturing systems, including filling operations, environmental monitoring, and contamination control strategies • Support process validation, media fill readiness, and inspection readiness activities for aseptic manufacturing • Ensure compatibility of process and packaging systems with cleanroom environments (Grade A/B/C/D) and sterile handling requirements • Identify and mitigate risks related to aseptic process robustness, contamination control, and operator/environmental interactions