API Engineering Manager

3 weeks ago


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

At BioSpace, Inc., we strive to make a positive impact on people's lives by developing innovative solutions in the field of pharmaceutical manufacturing. We are a global leader in the industry, and our employees work together to discover and bring life-changing medicines to those who need them.

Our team is dedicated to improving the understanding and management of disease, and we give back to our communities through philanthropy and volunteerism. We are looking for a talented individual to join our team as an API EM Process Engineer.

Key Responsibilities
  • Develop and sustain process knowledge to ensure the execution of the appropriate product, process, and operational control strategy at a number of Contract Manufacturers (CMs)
  • Direct and indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy
  • FUME assessment to ensure an understanding of risk presented to the operational control strategy
  • Participation with internal or CM resources in the equipment specification, procurement, and IQ/OQ/PQ
  • Participation with internal and CM resources to assess the HSE and PSM elements of the CM that impact Lilly products
Requirements
  • 5 years of work experience in a manufacturing/process engineering related role
  • Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive chemical manufacturing experience
Preferred Qualifications
  • Experience in typical unit operations for Large Molecule API Manufacturing manufacturing
  • Deep technical knowledge of API / Drug Substance manufacturing equipment and unit operations
  • Demonstrated ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and talented individual who is passionate about making a difference in the world, we encourage you to apply for this exciting opportunity.


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