Principal Specialist, Tech Support

Jobs2Web; Athens (GA); On-site; USD 120,000 - 150,000; Full time

Job summary

Boehringer Ingelheim is seeking a Principal Specialist to provide technical support and ongoing process monitoring for vaccine manufacturing. You will interact with operations teams, maintain technical data, and lead troubleshooting efforts within a heavily regulated setting to ensure product quality and compliance.

Ideal candidates have a strong background in biology with extensive experience in regulated biopharmaceutical processes, data analysis, and cross-functional collaboration between IO,

Qualifications

• Bachelor of Science in Biology or related field is required.
• 5+ years of industry experience in a regulated environment is required.
• Advanced degree (MS/PhD) preferred with 10+ years of industry experience.
• Experience with DM AIC, root cause analysis, and process monitoring is required.

Responsibilities

• Escalate production flow disturbances and participate in root cause identification.
• Maintain technical data and support documentation.
• Lead technical team for process monitoring.
• Develop troubleshooting protocols for production outlines.
• Collaborate with QA, RA for Change Control Requests and Product Quality Reviews.

Skills

Root cause analysis

DMAIC methodology

Statistical analysis

Process monitoring

Technical writing

Regulatory interface

Cross-functional collaboration

Communication with operations

Education

Bachelor of Science in Biology or related field

Master of Science in Biology or related field

Doctorate in Biology or related field

Job description

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.