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Lead Quality Engineer in Pharmaceutical Manufacturing

2 months ago

Indianapolis, Indiana, United States Lantheus Medical Imaging Inc Full time
Job Overview

Lantheus Medical Imaging Inc., a leader in the medical imaging sector, is seeking a Senior Pharmaceutical Quality Engineer to enhance our quality assurance capabilities. With a legacy of over 60 years, we are dedicated to advancing patient care through innovative diagnostics and therapeutic solutions.

Position Summary

The Senior Pharmaceutical Quality Engineer plays a pivotal role in overseeing the quality aspects of aseptically filled radiopharmaceutical products manufactured by Contract Manufacturing Organizations (CMOs). This position involves the development, implementation, and assessment of processes and procedures to ensure compliance with industry standards and regulations.

Key Responsibilities

  • Act as the primary Quality Assurance representative in managing CMO change control, investigations, and CAPA (Corrective and Preventive Actions) while adhering to regulatory and business requirements.
  • Oversee routine manufacturing operations, ensuring compliance through evidence-based, risk-oriented solutions.
  • Collaborate with diverse teams within manufacturing and technical departments to meet product quality and safety standards.
  • Lead investigations at CMOs, employing root cause analysis to identify issues and implement effective CAPA strategies.
  • Manage CMO Supplier Change Notification records and represent Quality Assurance in various team meetings and initiatives.
  • Monitor and report on CMO performance metrics, ensuring alignment with quality objectives.
  • Review and approve validation documents, protocols, and procedures, both internally and externally.
  • Serve as a technical resource during inspections by regulatory bodies.
  • Notify management of critical quality issues impacting manufacturing timelines and propose viable solutions.
  • Support review board meetings as necessary.
  • Maintain up-to-date knowledge of FDA regulations and guidance relevant to the pharmaceutical industry.

Qualifications

  • Bachelor's degree in a scientific discipline with a minimum of 5 years of relevant experience in the pharmaceutical or radiopharmaceutical sector.

Preferred Experience

  • Experience in aseptic fill-finish processes and validation of manufacturing technologies.
  • Background in Quality Control or Manufacturing within an aseptic processing environment.
  • Familiarity with handling hazardous materials and adherence to safety protocols.
  • Willingness to travel up to 20% as required.

Core Values

The ideal candidate will embody Lantheus's core values:

  • Empower individuals to excel
  • Foster mutual respect and teamwork
  • Embrace learning and adaptability
  • Recognize the importance of health in our work
  • Take ownership of solutions and drive results

Lantheus is committed to fostering an inclusive workplace and values diversity in its workforce. We are an equal opportunity employer and do not discriminate based on any protected characteristic.