Current jobs related to Lead Quality Engineer in Pharmaceutical Manufacturing - Indianapolis, Indiana - Lantheus Medical Imaging Inc

  • Senior Pharmaceutical Quality Engineer

    2 weeks ago

    Indianapolis, Indiana, United States Lantheus Full time

    Job SummaryWe are seeking a highly skilled Senior Pharmaceutical Quality Engineer to join our team at Lantheus. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our radiopharmaceutical products.Key Responsibilities:Provide quality oversight of routine manufacturing operations, ensuring...

  • Senior Chemical Engineer

    2 months ago

    Indianapolis, Indiana, United States Catalyst Life Sciences Full time

    We are seeking a highly experienced Senior Chemical Engineer to join our team at Catalyst Life Sciences. As a key member of our organization, you will be responsible for leading the development and implementation of chemical engineering solutions for our pharmaceutical clients.Key Responsibilities:Develop and implement chemical engineering solutions for...

  • Manufacturing Engineer Team Lead

    6 days ago

    Indianapolis, Indiana, United States Kimball Electronics Full time

    We are committed to providing reasonable accommodations for individuals with disabilities in our job application process. If you need assistance or an accommodation during the application or recruitment process due to a disability, you may contact us. We will treat all requests for accommodations discreetly.The mission of the Manufacturing Engineering Team...

  • Manufacturing Engineering Team Lead

    6 days ago

    Indianapolis, Indiana, United States Kimball Electronics Full time

    We are seeking a highly skilled Manufacturing Engineering Team Lead to join our team at Kimball Electronics. As a key member of our engineering team, you will be responsible for providing leadership to the manufacturing engineering team by building, managing, and directing the Manufacturing Engineering Department. This includes establishing and enforcing...

  • Manufacturing Engineering Team Lead

    2 weeks ago

    Indianapolis, Indiana, United States Kimball Electronics Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Engineering Team Lead to join our team at Kimball Electronics. As a key member of our engineering department, you will be responsible for leading the manufacturing engineering team and establishing/enforcing engineering processes and procedures.Key ResponsibilitiesDevelop and implement manufacturing...

  • Manufacturing Engineer Team Lead

    2 weeks ago

    Indianapolis, Indiana, United States Kimball Electronics Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Engineer Team Lead to join our team at Kimball Electronics. As a key member of our manufacturing engineering team, you will be responsible for providing leadership and direction to the team, ensuring the development and implementation of engineering processes and procedures.Key ResponsibilitiesProvide...

  • Manufacturing Engineering Lead

    2 months ago

    Indianapolis, Indiana, United States Westlake Full time

    Job SummaryWestlake is seeking a highly skilled Process Engineer to lead innovative manufacturing engineering projects and drive operational excellence in our Marion, VA facility. As a key member of our team, you will partner with cross-functional teams to develop and implement process improvements, ensuring the highest level of quality and efficiency in our...

  • Manufacturing Engineer

    4 weeks ago

    Indianapolis, Indiana, United States LHH Full time

    Manufacturing Engineer Job DescriptionLHH is seeking a skilled Manufacturing Engineer to join our team in Indianapolis, IN. As a key member of our Engineering Team, you will be responsible for developing and implementing effective manufacturing processes, ensuring the highest quality products, and driving process improvement initiatives.Key...

  • Manufacturing Engineer

    2 weeks ago

    Indianapolis, Indiana, United States LHH Full time

    Manufacturing EngineerLHH is seeking a skilled Manufacturing Engineer to join a dynamic team in Indianapolis, IN. As a key member of our engineering team, you will report to an Engineering Manager who fosters innovation and growth. In this role, you will have the opportunity to work with various manufacturing equipment and product lines, lead projects to...

  • Quality Manufacturing Engineer

    2 weeks ago

    Indianapolis, Indiana, United States Belcan Corporation Full time

    Job Summary:Belcan Corporation is seeking a Quality Manufacturing Engineer to join our team in Indianapolis, IN. As a Quality Manufacturing Engineer, you will be responsible for maintaining and improving data collection methods, analysis, and dissemination to describe quality performance of products and processes. You will collaborate with management on...

  • Principal Engineer

    6 days ago

    Indianapolis, Indiana, United States Eli Lilly Full time

    At Eli Lilly, we are committed to delivering life-saving medications to patients worldwide. As a Sr. Principal Engineer in our Device and Packaging Manufacturing division, you will play a pivotal role in supporting our mission.Key Responsibilities:Provide technical oversight and guidance on the development and optimization of automated assembly...

  • Pharmaceutical Packaging Room Leader

    3 weeks ago

    Indianapolis, Indiana, United States Thermo Fisher Scientific Full time

    Job DescriptionThermo Fisher Scientific is seeking a highly skilled Pharmaceutical Packaging Room Leader to join our team. As a key member of our clinical trials packaging operation, you will be responsible for timely and accurate assembly and/or labeling of pharmaceutical clinical drug trial treatments following associated manufacturing regulatory standards...

  • Manufacturing and Engineering Executive

    6 days ago

    Indianapolis, Indiana, United States Cork Medical Full time

    **Director of Manufacturing and Engineering Job Description**Cork Medical is seeking a highly skilled and experienced Director of Manufacturing and Engineering to lead our manufacturing and engineering functions. The successful candidate will be responsible for overseeing all aspects of our day-to-day manufacturing and engineering operations, ensuring that...

  • Manufacturing and Engineering Leadership Position

    3 days ago

    Indianapolis, Indiana, United States Cork Medical Full time

    DIRECTOR OF MANUFACTURING AND ENGINEERING JOB DESCRIPTIONJob Summary:The Director of Manufacturing and Engineering will lead the manufacturing and engineering functions of Cork Medical, overseeing production and quality management to ensure company goals are met.Key Responsibilities:• Strategize and coordinate the work of engineering and manufacturing...

  • Manufacturing Engineer

    2 weeks ago

    Indianapolis, Indiana, United States GTC Machining, LLC Full time

    Job Title: Manufacturing EngineerAt GTC Machining, LLC, we are seeking a highly skilled Manufacturing Engineer to join our team. As a key member of our operations team, you will be responsible for bridging sales and service with operations, resulting in improved on-time delivery, customer satisfaction, and profitability.Key Responsibilities:Provide...

  • Visual Inspection Mentor

    1 week ago

    Indianapolis, Indiana, United States BioSpace, Inc. Full time

    Job Summary:The Visual Inspection Mentor is a key member of a cross-functional team providing technical guidance for inspection operations and projects involving existing and new inspection processes.Responsibilities:Provide technical oversight regarding defect classification, visual inspection technique, and visual inspection qualification program to...

  • Senior Quality Assurance Specialist

    6 days ago

    Indianapolis, Indiana, United States Stefanini Group Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Engineer to join our healthcare manufacturing team. The ideal candidate will have a strong background in IV bag or IV solutions manufacturing and experience in a regulated manufacturing environment. This role requires a hands-on approach to ensure that all products meet the highest quality standards...

  • Automation Engineer-Device Manufacturing

    6 days ago

    Indianapolis, Indiana, United States BioSpace, Inc. Full time

    Job Title: Automation Engineer-Device ManufacturingWe are seeking an experienced Automation Engineer to join our Device Manufacturing team. As an Automation Engineer, you will be responsible for designing, developing, and implementing automated device assembly lines for our global manufacturing sites and contract manufacturers.Key Responsibilities:Provide...

  • Quality Assurance Engineer

    3 weeks ago

    Indianapolis, Indiana, United States Lilly Full time

    About LillyLilly is a global healthcare leader dedicated to making life better for people around the world. With a presence in over 70 countries, we are committed to discovering and bringing life-changing medicines to those who need them. Our employees work together to improve the understanding and management of disease, and give back to our communities...

  • Pharmaceutical Packaging Operations Manager

    6 days ago

    Indianapolis, Indiana, United States ThermoFisher Scientific Full time

    Job SummaryWe are seeking a highly skilled Pharmaceutical Packaging Room Leader to join our team at Thermo Fisher Scientific. In this role, you will be responsible for timely and accurate assembly and/or labeling of pharmaceutical clinical drug trial treatments following manufacturing regulatory standards and procedures.Key ResponsibilitiesReview daily...

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. is a leader in the medical imaging field, committed to enhancing patient care through innovative diagnostics and therapeutics. With a strong presence in the industry for over six decades, we are dedicated to fostering a collaborative and inclusive environment.

Position Summary

The Senior Pharmaceutical Quality Engineer plays a crucial role in overseeing the quality assurance processes associated with the manufacturing of aseptically filled radiopharmaceutical products. This position involves ensuring compliance with regulatory standards and company protocols while working closely with Contract Manufacturing Organizations (CMOs).

Key Responsibilities

  • Act as the primary Quality Assurance representative during CMO change management, investigations, and CAPA reviews, ensuring adherence to regulatory and business standards.
  • Oversee routine manufacturing operations, analyzing data from various departments to identify compliant solutions based on a risk-based approach.
  • Collaborate with diverse teams within manufacturing and technical departments to ensure product quality and compliance.
  • Lead investigations into CMO processes, employing root cause analysis to identify issues and implement corrective actions.
  • Manage CMO Supplier Change Notification records as the primary Quality representative.
  • Participate in team meetings and initiatives, representing Quality Assurance in discussions with CMOs.
  • Oversee CMO metric management, including data trending and reporting.
  • Review and approve protocols, validation documents, and procedures, both internally and externally.
  • Serve as a technical resource during FDA inspections and other regulatory audits.
  • Notify management of critical issues impacting manufacturing objectives, proposing viable solutions.
  • Support Investigation Review Board and Change Control 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 industry.

Preferred Experience

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

Core Values

The ideal candidate will embody the core values of Lantheus:

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

Lantheus is committed to equal employment opportunities and values diversity in the workplace.