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Position Brand Description:

The EM associate assists in the safe, compliant execution of the environmental monitoring (EM) program for the Research Triangle Park Facility for Lilly production areas (a 24/7 operation).  This role is responsible for process monitoring and improvement, issue resolution/investigation, EM data system steward, and acts as a liaison between EM and multiple areas in ownership and/or execution of improvements, projects, and change controls. 

Key Objectives / Deliverables:

Provide technical leadership to EM organization.Understand the scientific principles required for manufacturing parenteral drug products, including the components of a robust contamination control strategy.Assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk.Provide technical support for all start-up activities related to environmental monitoring sampling programs (e.g., environmental monitoring PQ, aseptic process simulations, etc.)Ensure site’s environmental monitoring, aseptic process simulations, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level, as they pertain to the EM organization.Provide technical guidance for environmental monitoring program and for root cause investigations related to this program.Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.Lead or support risk assessments related to EM program.Create, execute, review, and/or approve technical documents related to EM program, including those in support of batch release.Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends.Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring programsEnsure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Minimum Requirements:

Bachelor's degree in Microbiology, Biology, Biochemistry, or other related scientific discipline8+ years’ experience in parenteral manufacturing & environmental monitoring principles

Additional Preferences:

Strong proficiency in MODAEffective written and oral communication skills.Effective interpersonal skillsExperience supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services/MSAT, quality assurance, etc.)Strong self-management and organizational skillsFacility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulationsExperience with data trending and analysisAbility to analyze complex data and solve problems

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Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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