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

About the role

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.

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

Responsibilities

• Ensures availability of Boehringer Ingelheim products throughout lifecycle
• 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 (CPV), Control Strategy Summary (CSS), and Transport Qualification processes for assigned commercial products, to monitor product performance
• 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

Requirements

• Level IV: B.S. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of fifteen (15) years’ experience in pharmaceutical process or packaging engineering, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or twenty (20) years' experience in product development, process or packaging engineering in a related industry required.
• Level III: B.S. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of ten (10) years’ experience in pharmaceutical process or packaging engineering, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or twelve (12) years' experience in product development, process, or packaging engineering in a related industry.

Desired Skills, Experience and Abilities

• Performs Process, Packaging, or Transport Risk Assessments at applicable product lifecycle stages, balancing primary input from development partners with own critical process review and input; collaboratively identify critical risk areas and potential remediation plans for team review & selection of processes and systems.
• Acts as back-up/surge capacity for Product Launch Manager role.
• Leads cross-functional teams in design and execution of new product launch plans, coordinate with global development and US Asset teams to develop launch scenarios, communicate progress and issues throughout the project life to internal BI stakeholders and external suppliers and providers
• Mentors and cross-trains other Engineers in technical and procedural aspects of launch and lifecycle management.
• Coordinates directly with peers in corporate functions and production sites to share knowledge and best practices.