Associate Director - QC Environmental Monitoring

Eli Lilly and CompanyUs, IN
33d$123,000 - $180,400

About The Position

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. The Associate Director of QC Environmental Monitoring is responsible for the oversight of environmental monitoring sampling operations, environmental monitoring laboratories, FUME (utilities monitoring). This position requires the ability to multitask / prioritize, excellent written and oral communication skills, decision making ability, interpersonal skills, as well as the ability to anticipate potential problems then develop / implement alternative solutions.

Requirements

  • Previous supervisory experience
  • 7+ years microbiology and/or environmental monitoring experience, including:
  • Demonstrated technical competency (method understanding) and leadership in Environmental Monitoring of both traditional aseptic environments and isolators (e.g., viable monitoring – active and passive, non-viable monitoring, personnel monitoring).
  • Demonstrated technical competency (method understanding) and leadership in Utility Monitoring (e.g., Process Air, Water for Injection, Clean Steam).
  • Deep understanding of compliance requirements and regulatory expectations
  • Ability to work 8-hour days - Monday through Friday
  • Ability to work overtime as required
  • Available off shift to respond to operational issues
  • Minimal travel required.
  • Bachelor of Science in Biology / Microbiology or related science.

Nice To Haves

  • Six Sigma Green Belt or Black Belt certification.
  • MODA proficiency

Responsibilities

  • Oversight of microbiology equipment commissioning and qualification.
  • Demonstrated administrative leadership of a diverse team including performance management and personnel development.
  • Ability to utilize team through active engagement and delegation to achieve results through others and deliver according to plan.
  • Ability to manage a complex change agenda in a fast-paced environment.
  • Ability to manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates.
  • Ability to demonstrate flexibility with quick response as priorities change or issues arise.
  • Active communication on project status.
  • Partner with production and design operation to ensure 24/7 support for required testing and monitoring against production schedule
  • Review and approve technical and GMP documents such as protocols, deviations, changes, summary reports, etc
  • Ensure all aspects of safety are incorporated into the lab and maintain a safe work environment, including supporting all HSE Corporate and Site Goals.
  • Establish connections with the Global Quality Lab Network and actively working with the network to support global initiatives.
  • Establish Lean Lab and efficient lab operations with a process for monitoring lab performance and continuously improving the operation.
  • Define, lead and/or support inspection readiness activities for lab operations and interact with Regulatory agencies during inspections

Benefits

  • Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
  • In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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What This Job Offers

Job Type

Full-time

Career Level

Director

Number of Employees

5,001-10,000 employees

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