Description

A Principal Specialist will provide technical support and on-going process monitoring for all activities associated with the manufacture of animal health vaccines in order to support business objectives. 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 a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Escalation of production flow disturbances and participation in root cause identification with IO
• Maintenance of technical data and support documentation
• Technical team leadership and process monitoring for IO
• Lead / create / develop troubleshooting protocols within the Outline of Production
• Management and resolution of critical products & raw materials with QA & RA
• Collaborate with IO, QA, RA for Change Control Requests
• Participate / represent IO in Technical Change Review
• Management of annual Product Quality Review (PQR)

Requirements

• Required:
  • Bachelor of Science from an accredited institution in Biology or related field
  • Five+ (5+) years of industry experience
• Preferred:
  • Bachelor / Masters of Science from an accredited institution in Biology or related field
  • Ten+ (10+) years of industry experience
• Exceeds:
  • Masters / Doctorate of Science from an accredited institution in Biology or related field
  • Ten+ (10+) years of industry experience
• Experience interacting with operations teams, establishing lines of communication and providing real-time technical support in a highly regulated industry.
• Demonstrated experience with root cause identification, resolution and monitoring (DMAIC model).
• Industry experience leading diverse teams and resolving complex technical issues.
• Hands on experience with biological / pharmaceutical processing, automated control systems and industrial scale biological processes.
• Industry experience with technical writing and interface with US / international regulatory agencies.
• Proven experience with statistical analysis, control charting, process capability or related monitoring tools.

Desired Skills, Experience and Abilities

• Ideal candidates will have proven industry experience within a mid-large sized USDA / FDA regulated animal health or pharmaceutical company with clear commitment to maintaining regulatory compliance and achieving business objectives.