This position will provide technical and strategic stewardship of sterility assurance programs employed at the Indianapolis Parenteral Manufacturing site. The role involves use of risk-based approaches to define and assess sterility assurance controls for existing processes and new installations. Responsibilities will include developing and implementing targeted process improvements, as well as strategic-level transformations, to site sterility assurance programs. Oversight will include the integrated aspects of site TS/MS sterility assurance programs including: aseptic process simulations, cleaning / sanitization programs, aseptic manipulation / intervention programs, sterility assurance risk assessment strategies, discard strategies, filter validation, and sanitization agent validation. This position will lead and integrate initiatives that drive the highest sterility assurance standards across multiple functions including TS/MS, Environmental Monitoring, Operations, Engineering, and Quality Assurance. The role will also function as a sterility assurance subject matter expert and liaison for IPM across the global parenteral network.
Use of risk-based approaches (i.e. HAACP, FMEA, etc.) to evaluate existing parenteral products manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
Identification and definition of acceptable aseptic manipulations, and interventions and the associated controls, to be used in manufacturing processes based on risk analysis.
Execution of a risk-based approach to identify areas of highest risk in support of sampling location selection for Environmental Monitoring Performance Qualification and eventual identification of routine environmental monitoring sampling sites.
Lead or provide consultation for investigation of sterility assurance-related events and non-conformances.
Develop/maintain site programs for training and qualification of aseptic personnel.
Represent/defend site sterility assurance strategies during internal assessments/audits and external regulatory inspections.
Influences corporate guidance associated with sterility assurance.
Develop sterility assurance strategies to be employed for new facilities/utilities or processes.
Provide oversight of the site TS/MS integrated sterility assurance programs including: aseptic process simulations, cleaning / sanitization programs, aseptic manipulation / intervention programs, sterility assurance risk assessment strategies, discard strategies, filter validation, and sanitization agent validation.
Develop and implement targeted process improvements, as well as strategic-level transformations, to site sterility assurance programs.
Serve as a sterility assurance subject matter expert and liaison for IPM across the global parenteral network helping to drive change, harmonization and replication.
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.
Master’s Degree in Microbiology, Biology or a related scientific field
Minimum of 15 yrs. of experience in support of (parenteral) injectable products in pharmaceutical manufacturing.
Knowledge and understanding of cGMPs and global compliance expectations for aseptic processing (e.g. US FDA, EU, etc.)
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position.
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site goals.
Detailed knowledge and understanding of cGMPs and global compliance expectations for aseptic processing (e.g. US FDA, EU, etc.)
Technical leadership skills
Interpersonal skills including ability to effectively influence others
Technical writing and presentation skills
Ability to prioritize and attention to detail