Sterility Assurance Advisor – Technical Services/manufacturing Science (ts/ms)

Eli Lilly Eli Lilly · Pharma · Alzey, Germany

The Sterility Assurance Advisor role at Eli Lilly is responsible for maintaining a safe work environment and understanding the scientific principles required for manufacturing parenteral drug products. This includes using sterility assurance risk management to evaluate manufacturing processes and controls, leading projects associated with sterility assurance programs, and developing/executing process and facility monitoring strategies. The role also involves leading deviations, staying updated on regulatory requirements, influencing corporate guidance, identifying continuous improvements, providing design input for new processes, defending sterility assurance programs during audits, assisting with regulatory submissions, and providing training and technical mentorship.

What you'd actually do

  1. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
  2. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
  3. Lead major deviations for root cause analysis related to sterility assurance programs.
  4. Represents and defends the site’s sterility assurance programs during internal audits and external regulatory inspections.
  5. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites.

Skills

Required

  • BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
  • In depth knowledge and understanding of GMPs and internal standards
  • In depth knowledge of parenteral processing
  • In depth knowledge of microbiology and sterility assurance
  • In depth knowledge of risk management and the understanding / ability to use risk assessment tools
  • Ability to analyze complex data and solve problems
  • Strong technical writing and presentation skills
  • Teamwork / interpersonal skills ability to effectively influence

Nice to have

  • Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations
  • Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.)

What the JD emphasized

  • In depth knowledge and understanding of GMPs and internal standards
  • In depth knowledge of parenteral processing
  • In depth knowledge of microbiology and sterility assurance
  • In depth knowledge of risk management and the understanding / ability to use risk assessment tools