Technician - Sterility Assurance TSMS (Night Shift)
Eli Lilly and Company
19 days ago
On-site
Durham, NC
Operations
Technician - Sterility Assurance TSMS (Night Shift)
Role Responsibilities / Key Objectives
- Provide continuous support to parenteral operations to enhance assurance of sterile product manufacture.
- Coach, audit, and communicate within aseptic processing areas to reinforce best aseptic practices.
- Identify and report aseptic condition events in clean rooms during manufacturing.
- Communicate promptly with Operations on aseptic techniques and personnel behaviors.
- Gather, organize, and analyze data to develop compliant solutions/alternatives.
- Conduct periodic internal reviews/audits; ensure procedures are followed.
- Lead remediation for unplanned events and shutdown activities.
- Lead/coach/mentor personnel on aseptic techniques during manufacturing and during smoke studies/qualification.
- Provide technical support for non-routine investigations (deviations, complaints), including required studies.
- Execute/assist qualification/validation activities to support bioburden control; support other TS/MS routine responsibilities as assigned.
- Be a point of contact for aseptic operations and bioburden control.
- Ensure safe work practices and participate in safety activities to improve safety culture.
Minimum Requirements
- High school diploma or GED
- Minimum 2 years of pharmaceutical experience supporting cGMP manufacturing
- Experience with parenteral drug product manufacturing
Additional Preferences
- Aseptic processing, environmental monitoring, microbiology, equipment qualification/validation
- Data analysis/problem-solving; strong written/verbal communication
- Deviation/change management systems (e.g., Trackwise), Kneat
- Interpersonal/teamwork; self-management/independent work; task prioritization
Other Information
- 12-hour shifts on a 2-2-3 rotation; flexibility for production/shutdown needs; occasional extended/off-hour work.
Visa Sponsorship / Work Authorization
- No work authorization/visa sponsorship provided for this role.
Role Responsibilities / Key Objectives
- Provide continuous support to parenteral operations to enhance assurance of sterile product manufacture.
- Coach, audit, and communicate within aseptic processing areas to reinforce best aseptic practices.
- Identify and report aseptic condition events in clean rooms during manufacturing.
- Communicate promptly with Operations on aseptic techniques and personnel behaviors.
- Gather, organize, and analyze data to develop compliant solutions/alternatives.
- Conduct periodic internal reviews/audits; ensure procedures are followed.
- Lead remediation for unplanned events and shutdown activities.
- Lead/coach/mentor personnel on aseptic techniques during manufacturing and during smoke studies/qualification.
- Provide technical support for non-routine investigations (deviations, complaints), including required studies.
- Execute/assist qualification/validation activities to support bioburden control; support other TS/MS routine responsibilities as assigned.
- Be a point of contact for aseptic operations and bioburden control.
- Ensure safe work practices and participate in safety activities to improve safety culture.
Minimum Requirements
- High school diploma or GED
- Minimum 2 years of pharmaceutical experience supporting cGMP manufacturing
- Experience with parenteral drug product manufacturing
Additional Preferences
- Aseptic processing, environmental monitoring, microbiology, equipment qualification/validation
- Data analysis/problem-solving; strong written/verbal communication
- Deviation/change management systems (e.g., Trackwise), Kneat
- Interpersonal/teamwork; self-management/independent work; task prioritization
Other Information
- 12-hour shifts on a 2-2-3 rotation; flexibility for production/shutdown needs; occasional extended/off-hour work.
Visa Sponsorship / Work Authorization
- No work authorization/visa sponsorship provided for this role.