Technical Specialist

1 day ago

Indianapolis, Indiana, United States Lilly Full time
Unlock Your Potential at Lilly

We are a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. Our employees work together to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

Join Our Dynamic Team

We're seeking a talented Technical Specialist to join our Device and Packaging Manufacturing division. As a pivotal force in our team, you will provide technical oversight and support our mission to deliver life-saving medications to patients worldwide.

Key Responsibilities
  • Provide technical subject matter expertise and oversight for device and packaging areas
  • Liaise with regulatory functions to align on regulatory strategies and identify new technologies
  • Engage externally to stay current in evolving science, manufacturing technology, and regulatory environments
  • Prepare, review, and approve technical documentation and provide input on experimental findings
  • Independently identify key scientific questions and develop solutions to advance business objectives
Innovation and Problem-Solving
  • Provide technical and effective process support services for production issue resolution and investigation
  • Identify and drive improvement opportunities and implement the organization's technology transfer agenda
  • Support complex investigation of key issues and events and work on the identification and implementation of CAPA plans
Regulatory Compliance
  • Ensure adherence to current regulatory requirements, including cGMP standards and OSHA regulations
  • Support site inspection readiness and execution and interact with Regulatory Agencies during site inspections
  • Identify weaknesses and opportunities in control strategy and pursue improvements and resolution
Process Optimization
  • Develop local processes and procedures to enhance efficiency and effectiveness using lean tools
  • Use first principles and theoretical knowledge to define scientific approaches and improve product/process robustness
  • Perform process monitoring of critical parameters and react to signals/trends to drive continuous improvement
Cross Functional Collaboration
  • Foster knowledge sharing and education within the team and with key internal and external partners
  • Collaboratively integrate different disciplines on technical projects and process performance improvements
Mentorship
  • Mentor and provide coaching to develop other technical resources on scientific approach and technology
  • Create a safe and encouraging environment for colleagues to share ideas and contribute
Safety and Quality Culture
  • Lead by example in building and driving a culture of safety first and quality always
  • Author, review, and approve GMP documentation, including procedures and technical reports

Requirements:

  • Bachelor's Degree in Engineering, Science, or related fields
  • 5+ years of experience in a technical role of pharmaceutical manufacturing or regulated industry
  • Strong understanding of cGMPs and pharmaceutical or regulated industry manufacturing
  • Ability to lead complex technical projects and make informed decisions
  • Demonstrated strong technical leadership and communication skills
  • Ability to work well independently and in teams
  • Demonstrated strong analytical and problem-solving abilities

Preferred Qualifications:

  • Project management experience and basic statistical skills
  • Prior experience in packaging and/or dry/wet device assembling operations
  • Working knowledge of equipment and facility qualification processes
  • Safety equipment (PPE) and precautions required in the manufacturing plant environment
  • Travel may be required to support business needs

Lilly is an EEO/Affirmative Action Employer

We are committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs

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