Eli Lilly and Company-posted 2 days ago
Full-time • Mid Level
Onsite • Carolina, PR
5,001-10,000 employees

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work 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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview: The Quality engineer facilitates and enforces compliance with Good Manufacturing Practices (GMP) and corporate quality policies at the PR01 plant, focusing on utilities, equipment, computerized systems, and facilities in oral solid manufacturing. As part of the role will support project implementation for the site in all phases ensuring compliance with requirements and regulations. Support and oversight as Quality Unit for qualifications and all related documentation.

  • Ensure compliance with Good Manufacturing Practices (GMPs) and corporate quality policies with special attention to the following elements:
  • Participating in qualification strategies, change control evaluations, deviation assessments, periodic quality evaluations, procedure management, and documentation retention
  • Fulfill individual training plans, act as a quality procedure instructor and mentor, actively participate in Flow Team activities, and attend departmental meetings
  • Monitoring pest control and facility maintenance, supporting Lean implementation, evaluating validations and changes related to utilities, equipment, and facilities, and ensuring regulatory plan approvals
  • Ensures compliance with data integrity per 21 CFR Part 11, computerized system validation policies, and handles controlled substances according to legal and company requirements, including reporting deviations and illicit activities
  • Bachelor’s degree in Engineering (Chemical, Electrical or Mechanical)
  • Minimum of 3 years of experience in facilities, equipment, utilities and FDA regulated environment.
  • PE or EIT, preferred
  • Bilingual (English/Spanish) with strong written and oral communication skills
  • Strong leadership and organizational skills
  • Sound judgment
  • Teamwork oriented; ability to work cross functionally
  • Able to manage multiple project objectives or assignments
  • Strong customer service focus
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