SR Principal Specialist, Mfg Improvement

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The SR Principal Specialist, Manufacturing Improvement works with senior leadership, process scientists, and area leaders to partner and develop systems to monitor and optimize vaccine production processes. This role drives statistical process understanding and improvements by leveraging data assets (SCADA, SAP, QC databases, data warehouse, etc.) and advanced analytical tools (e.g., SIMCA, Minitab, JMP) to characterize performance of our processes with critical process parameters (CPP) or other yield indicators. The incumbent manages and improves Vaccine Production's data assets, develops tools and influences decisions on process monitoring technologies, and serves as the department's Subject Matter Expert for data analytics and predictive modeling.

Duties & Responsibilities

• Provides technical leadership, guidance, and influence on processes and strategies for yield improvements, troubleshooting, root cause analysis, SME input on manufacturing deviations, validation activities, analytical tests, etc. related to vaccine production May direct and oversee key projects within the Vaccine Production organization.
• Identifies process improvement opportunities utilizing our data assets (SCADA, SAP, QC databases, data warehouse, etc.) and advanced analytical tools (e.g., SIMCA, Minitab, JMP) in collaboration with Vaccine Production departments, Data Analytics, Production Technical Support (PTS) and QC.
• Analyzes complex biological processes and production data and prepares reports that identify and prioritize process problems and opportunities leading to more robust processes.
• Determines sources of process variation including measurement systems, process equipment, process execution, and raw materials.
• Leads strategy development, deployment of technical solutions for process optimization/improvement of all phases of vaccine production with the goals of improving process stability, yields, and cost of goods.
• Continually develops and maintains an appropriate level of theoretical and practical expertise to respond to the needs of vaccine production.
• Researches and uses scientific and technical publications and internal resources (SMEs) to gain process insight.
• Prepares feasibility assessments and technical reports that support go/no-go decisions on the implementation of new technologies or programs aimed at continuous improvement.

Requirements

• Bachelor's degree in scientific, engineering, business, or related field. Scientific discipline is preferred (Pharmacy, Chemistry, Biochemistry, or Biological Sciences).
• In addition to bachelor's degree, a minimum of eight (8) years of demonstrated manufacturing improvement experience within a regulated manufacturing environment or similar organization.
• In lieu of bachelor's degree, a Master's Degree in scientific, engineering, business, or related field and a minimum of five (5) years of demonstrated manufacturing improvement experience within a regulated manufacturing environment or similar organization.

OR

• Ph.D. in scientific, engineering, business, or related field and a minimum of three (3) years of demonstrated manufacturing improvement experience within a regulated manufacturing environment or similar organization. Experience must be inclusive of at least three (3) years of experience leading, influencing and developing across the organization either directly and/or indirectly.
• Additionally, ability to effectively identify and utilize resources to drive process improvement projects resulting in cost savings.
• Strong capabilities in Process Improvement Methods including leadership, training, and coaching roles.
• Proven coaching and mentoring capabilities to improve depth and breadth of Vaccine Production process knowledge and understanding.
• Thorough understanding and technical application of Good Manufacturing Practice (GMP) regulations.
• Responsible and accountable for excellent presentation, technical business writing, and communication of information for varied audiences.
• Must be proficient in Office software, including Microsoft Project, Excel, Word, and Power Point.
• Proficiency in statistical tools.

Desired Skills, Experience and Abilities