Sterile Manufacturing

BoehringerPRD•Columbus, OH

44d•Hybrid

About The Position

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

Requirements

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 (for Level IV).
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 (for Level III).
Working knowledge of experimental methodology and design of experiments to support pharmaceutical development/process transfer/validation.
Ability to define root cause relationships, collect data, establish facts, and draw valid conclusions.
Ability to apply the PDCA principles (plan, do, check, act).
Demonstrated ability to learn functionality and troubleshooting of pharmaceutical manufacturing equipment and understanding of the impact of critical equipment parameters on key product performance parameters at the expert level.
Proficient computer skills with the ability to enter data into and retrieve information from various software programs such as Microsoft Office (Work, Excel, PowerPoint, and Outlook).
Organizational skills and ability to facilitate execution of project milestones using project management skills.
Works under direct supervision for strategic decisions and with minimal supervision for tactical execution of tasks of moderate complexity. Exercises moderate latitude in determining objectives and approaches to assignments.
Ability to be an active participant on teams of moderate to high complexity, and to lead/facilitate teams on tasks of moderate complexity.
Skills to effectively educate colleagues on technical principles, process fundamentals, etc. (e.g. explaining critical process issues at meetings).
Demonstrated business acumen.
Working knowledge of and ability to apply investigative techniques to uncover problem areas, determine root causes, and recommend corrective actions.
Uses problem solving abilities requiring attention to detail, accuracy, and scientific judgment.
Develops solutions to a variety of problems of moderate scope and complexity, as defined in Accountabilities section.
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.

Responsibilities

Ensures availability of Boehringer Ingelheim products throughout lifecycle
Provide 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.
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).
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
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.